Product Manager

Project Management Engineer

Product & Business Development Manager (Pharma)- Hospital Care / Women’s Health

Cyber Security Sales Specialist

Site Investigation Lead, Quality Assurance

Product Manager & Business Development Manager (Pharma)

Manager I R&D/Product DVL Engineering - Electronic and Sensor Integration

Operations Supervisor

Quality Control Supervisor

QC Chemist I

Role Description: <ul><li>The Product Manager develops and helps execute product-level strategies.</li><li>Strategies will be based on market analysis, company objectives and product profitability, and will include recommendations on market share targets and customer bid tactics.</li><li>This position will also develop forecasts for existing and new products and work cross-functionally with Finance, Sales, Supply Chain, Portfolio Management and Regulatory.</li><li>The role requires having oversight of the commercialized products and near-term launches, providing inputs to long-range business cases and plans, and preparing support documents &amp; analytics for execution of sales activities.</li></ul> Responsibilities: Product Strategy <ul><li>Analyze market landscape using IQVIA and other data sources.</li><li>Recommend market share targets based on current share, # of competitors, cost position, supply capabilities and other factors.</li><li>Maintain product dashboard that provides relevant information to management and cross-functional team.</li></ul> Forecasting &amp; S&amp;OP <ul><li>Update and provide by-sku / by-customer forecasts to Finance and Supply Chain for use in official financial forecasts, incentive comp and supply plan forecasts.</li><li>Calculate and report forecast accuracy and customer award compliance measures.</li><li>Develop new forecasting tools and optimize existing models.</li><li>Support the Sales and Operations Planning (S&amp;OP) process reviews.</li></ul> New Products&nbsp; <ul><li>Co-lead the launch preparation process with the Launch Management team.</li><li>Work closely with Portfolio Management on business cases in order to prioritize launch sequencing and justify development/licensing/acquisition of new products.</li></ul> Other Commercial Operations Support <ul><li>Provide supporting documentation to Sales team such as sell sheets, analysis and other items needed to execute sales tactics.</li><li>Co-ordinate with cross functional team and ensure product information updated on our client portal.</li><li>Work with sales team and consultant to create and maintain VA website login.</li><li>Other items as assigned/identified.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in business, Finance, Analytics preferred.</li><li>MBA or masters degree in Analytics/Statistics preferred.</li><li>Minimum 3 years of generic pharmaceutical industry experience in inline/pipeline forecasting or Data Analytics.</li><li>Intellectual curiosity to go beyond the numbers/bring strategic ideas and insights.</li><li>Strong technical skills to build analytical tools, leverage secondary data and rollout plans.</li></ul> Knowledge <ul><li>Expert with MS office Suite, primarily MS Excel?Experience with SAP, Salesforce and IQVIA a plus.</li></ul> Skills &amp; Abilities <ul><li>Self-direct activities based on general direction given.</li><li>Handle multiple projects in a fast-paced team environment.</li><li>Identify priorities based on profitability and company objectives.</li><li>Create detailed business analysis, outlining problems, opportunities, and solutions.</li><li>Excellent analytical, mathematical, and creative problem-solving skills</li><li>Collaborate cross-functionally with Sales, Finance and Procurement colleagues to develop, analyze and implement strategic plans that maximize profitability.</li><li>Develop and maintain decision support systems that collect and synthesize sales data into knowledge that drives management decisions including resource allocations, opportunity identification, performance against expectations, and sales incentives.</li><li>Expand knowledge and experience by regular engagement with key stakeholders to understand business processes, policies, strategies and evolving business trends.</li><li>Interact with the team, management, and across departments to communicate changes to both current and proposed forecast changes.</li><li>Provide feedback and follow up communications across organization on any issues or market challenges.</li><li>Closely monitor the changing competitor landscape, turning insights into actionable and appropriate product strategies.</li><li>Review and recommend key products to stimulate profitable sales.</li><li>Ability to perform product profitability analyses and run multiple, complex scenarios and present to management for review/approval.</li><li>Brainstorm both short-term and long-term sales and profitability milestones and goals.</li></ul> Physical Requirements <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li></ul>

Responsibilities: <ul><li>Manage the overall project process, controlling schedule and quality to ensure timely delivery.</li><li>Develop project plans and set milestones during the initial stage.</li><li>Track progress of tasks, hold meetings when necessary, and drive team members to complete tasks efficiently.</li><li>Coordinate with procurement, cost, logistics, production staff, and suppliers to ensure smooth execution of project activities.</li><li>Review project budgets and costs; conduct tooling strategy meetings.</li><li>Identify alternative resources to reduce costs and make directional decisions based on project requirements.</li><li>Assess potential risks and arrange preventive actions to avoid them.</li></ul> Requirements: <ul><li>5–8 years of solid project management experience, especially with APQP and&nbsp;</li><li>PPAP quality knowledge and related project process management.</li><li>Age: under 40 years old.</li><li>Education: Bachelor’s degree (full-time) in engineering, preferably mechanical engineering or related fields.</li><li>Degrees in business administration, language, or arts will not be considered.</li><li>Work location: Building G1, No. 88 Dongchang Road, Suzhou Industrial Park (Suzhou 2.5 Industrial Park).</li></ul>

Responsibilities: Lead the development of launch plans and tactics, engaging in activities such as Brand Strategy, Strategic/Operational Planning and Execution. This position covers the Malaysian market. Marketing Planning (40%): <ul><li>Strategic planning and leadership to drive brand performance in ensuring successful market penetration (Prelaunch preparedness and go to market strategies)</li><li>Develop programs to maximize field selling efforts such as sample strategy, sales meetings, and all sales force related marketing activities.</li><li>Development of the annual brand business and budget plan, strategy &amp; objectives</li><li>Develop and plan resource allocation effectively to address changing market dynamic and competitions</li></ul>&nbsp;New portfolio exploration and business development (35%): <ul><li>Develop patient flow and product forecast based on the product analysed</li><li>Conduct market insights for new product (market data analysis, gather insights from HCPs)</li><li>Build business case for the new portfolio encompassing the pharma range (prescription drug), and consumer health</li><li>Perform business pitch to the principals</li></ul>&nbsp;Marketing Implementation (25%): <ul><li>Formulate, direct and coordinate all customer segment marketing activities and tactics to launch and promote the brand, working with agencies and cross functional partners.</li><li>Create and enhance relationships, internal and external, that contribute towards establishing the brand (key customers, thought leaders, associations and industry players) and implement establish KOL strategy</li><li>Manage brand budget efficiently</li><li>Timely development of promotional program/ materials that enables effective delivery of marketing messages</li><li>Support CMEs &amp; conduct product trainings to field-force</li></ul>&nbsp;﻿Requirements: <ul><li>Bachelor’s Degree in Science. Proficient in English.&nbsp;</li><li>Minimum 2-3 years of PM experience in pharma MNC</li><li>Past experience working in generic company (as sales representative or PM)</li><li>Has knowledge in these key healthcare channels: GP, private hospital, public hospital and retail pharmacy</li><li>Customer focused with strong interpersonal skills and able to illustrate agility to work and manage cross-functional teams.</li><li>Able to demonstrate new pilots in the areas of digital and analytics</li><li>Detail oriented and having the ability to actively listen.</li><li>Solid communication skills including presentation, verbal and written abilities. Shortlisted candidates are required to do a business case project.</li><li>Strategically focused, results oriented with strong problem-solving skills</li></ul>

Responsibilities: <ul><li>Indian enterprise sector is going through huge digital transformation.</li><li>Areas like Cloud adaption, Advanced Analytics, AI, IOT, Block chain &amp; Robotic Process Automation, Information Security are key building block towards this transformation.</li></ul> You would be responsible for Building Security Business pipeline &amp; achieve the Security Annual targets in the large enterprise segment <ul><li>Lead Large Customer Engagement with CISO level conversation within top enterprises and conglomerate.</li><li>Support Sales Account Management (AM’s) as Cyber Security Sales Specialist in large complex projects (comprising of Zero Trust Architecture, Securing cloud work loads, transforming SOC, Micro segmentation and others)</li><li>Understand the client/sector requirements and Map Security products &amp; Services &amp; Build Solution Stack for Sales Account Managers</li><li>Understand NIST, CERTIN guidelines, mitre att&amp;ck framework, OT Security. Good understanding of Security products.</li><li>Well engaged with Tier-1 &amp; Tier-2 SI</li><li>Drive Security product sales within commercial segment in Manufacturing, PSU, ITeS, Digital Native and Pharma</li></ul> Who Youll Work With <ul><li>GSSO – SE team.</li><li>Account Manager.</li><li>Product Engineering BU across vertical.</li><li>Regional SE Team.</li><li>Regional Channel Team.</li></ul> Requirements: <ul><li>8-10 Years of experience in Security OEM / Service Provider Environment in managing Sales/ Pre-Sales/Product Management function</li><li>Good understanding of business scenarios with solution expertise to formulate a realistic and executable strategy for Security adoption among enterprises.</li><li>Possess blend of technology expertise across various cyber security vendors, enterprise networks, datacenter, cloud networking and Information systems security.</li><li>Good connects with Cybersecurity decision makers in enterprises</li><li>Lead Large Customer Engagement with CISO level conversation within top enterprises and conglomerate.</li><li>Support Sales Account Management (AM’s) as Cyber Security Sales Specialist in large complex projects (comprising of Zero Trust Architecture, Securing cloud work loads, transforming SOC, Micro segmentation and others).</li><li>Understand the client/sector requirements and Map Security products &amp; Services &amp; Build Solution Stack for Sales Account Managers</li><li>Understand NIST, CERTIN guidelines, mitre att&amp;ck framework, OT Security. Good understanding of Security products.</li><li>Well engaged with Tier-1 &amp; Tier-2 SI</li><li>Drive Security product sales within commercial segment in Manufacturing, PSU, ITeS, Digital Native and Pharma</li></ul>

Responsibilities: Investigation Management <ul><li>Timely review and support to closing of OOS/OOT/Deviations/Market complaints/Customer notifications as an investigational SME Role.</li><li>Review and ensure identified Root cause/Hypothesis is based on sound scientific Rationale and evidence.</li><li>Review and ensure Investigation order is proper and logical.</li><li>Review and ensure Investigation articulation is proper and not Misleading /Ambiguous.</li><li>Review and ensure Identification of CAPA’s is consistent with investigation findings</li><li>Provide appropriate rating to Root cause investigation based on Hypothesis, Investigation order, Investigation articulation and Identification of CAPA’s.</li><li>Undertake continuous trainings and developments from an outcome of Investigations and CAPA’s.</li><li>Implementation of best practices in Investigation review mechanism, policies, processes and procedures to aid and improve operational performance and Quality Metrics.</li><li>Support to Implement all relevant procedures described in the Quality Management System (QMS) like Deviation, RCI, Complaint management etc.,</li><li>Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance.</li><li>Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy.</li><li>Review and identify areas of improvement in the investigations.</li><li>Ensure the compliance with current industrial practices and constantly meet the regulatory requirement with zero integrity issue.</li></ul> Workload Management&nbsp; <ul><li>Coordinate workload sharing with Investigators team and develop action plans to improve timeline and quality of investigations</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li></ul> Staff Development	 <ul><li>Evaluate potential candidates for Investigation team, performance evaluation of direct reports.</li></ul> Requirements: Education &amp; Experience&nbsp; <ul><li>Bachelor’s degree in pharmacy, Chemistry, Biotechnology, or related scientific discipline (master’s preferred)</li><li>10+ years of experience in pharmaceutical manufacturing, quality, or compliance roles, including investigation management</li><li>Prior experience leading teams and conducting root cause analysis for deviations, OOS/OOT, and quality events</li><li>Working knowledge of FDA, EU, and other global regulatory requirements Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>In-depth understanding of cGMP regulations, 21 CFR Part 211, ICH Q9/Q10 principles</li><li>Strong knowledge of manufacturing and QC processes for solid oral dosage forms, non-sterile liquids and semi-solid dosage forms</li><li>Familiarity with investigation tools and techniques (e.g., 5 Whys, Fishbone, FMEA)</li><li>Experience with Quality Management Systems (e.g., TrackWise, MasterControl)</li><li>Skills &amp; Abilities Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support - Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People - Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li><li>Excellent analytical thinking and problem-solving skills</li><li>Excellent critical thinking and root cause analysis skills</li><li>Ability to work cross-functionally and influence without authority</li><li>Proven ability to meet deadlines while handling multiple investigations</li></ul> Physical Requirements <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Ability to work on-site full-time in both office and GMP environments</li><li>Sit or stand for extended periods; walk between manufacturing and laboratory areas</li><li>Ability to occasionally lift or move materials up to 25 pounds</li><li>Use of personal protective equipment (PPE) as required Investigation Management</li></ul>

Responsibilities: Marketing Planning (40%): <ul><li>Strategic planning and leadership to drive brand performance in ensuring successful market penetration (Prelaunch preparedness and go to market strategies)</li><li>Develop programs to maximize field selling efforts such as sample strategy, sales meetings, and all sales force related marketing activities.</li><li>Development of the annual brand business and budget plan, strategy &amp; objectives</li><li>Develop and plan resource allocation effectively to address changing market dynamic and competitions</li></ul> New portfolio exploration and business development (35%): <ul><li>Conduct market insights for new product (market data analysis, gather insights from HCPs)</li><li>Develop patient flow and product forecast based on the portfolio analysed</li><li>Build business case for the new portfolio encompassing the pharma range (prescription drug), medical devices and consumer health</li></ul> Marketing Implementation (25%): <ul><li>Formulate, direct and coordinate all customer segment marketing activities and tactics to launch and promote the brand, working with agencies and cross functional partners.</li><li>Create and enhance relationships, internal and external, that contribute towards establishing the brand (key customers, thought leaders, associations and industry players) and implement establish KOL strategy&nbsp;</li><li>Manage brand budget efficiently</li><li>Timely development of promotional program/ materials that enables effective delivery of marketing messages</li><li>Support CMEs &amp; conduct product trainings to field-force</li></ul> Requirements: <ul><li>Bachelor’s Degree in Science. Proficient in English.&nbsp;&nbsp;</li><li>Minimum 2-3 years of relevant experience in marketing.&nbsp;</li><li>Has knowledge in these key healthcare channels: GP, private hospital, public hospital and retail pharmacy&nbsp;</li><li>Customer focused with strong interpersonal skills and able to illustrate agility to work and manage cross-functional teams.&nbsp;</li><li>Able to demonstrate new pilots in the areas of digital and analytics</li><li>Detail oriented and having the ability to actively listen.</li><li>Solid communication skills including presentation, verbal and written abilities. Shortlisted candidates are required to do a business case project.&nbsp;</li><li>Strategically focused, results oriented with strong problem-solving skills</li></ul>

Role Description: <ul><li>The Electronic and Sensor Integration Team Manager will report to the product development team for cold applied products, part of Energy Business unit.</li><li>S/he will lead &amp; be responsible for managing a team working on new product development (NPD), value analysis and value engineering (VA/VE) and sustaining projects as well as perform management duties.</li><li>This role will require strong leadership skills and demonstrated product development experience in a global technology company to drive success for the Energy BU by leading his/her team to develop best-in-class engineering solutions for our customers.</li></ul> Responsibilities: <ul><li>Manage and drive the Electronic and Sensor Integration Team.</li><li>Demonstrate technical leadership. Provide technical solutions and break through ideas.</li><li>Guide the development of complex electronic systems, including analog and digital circuits.</li><li>Oversee the implementation of emerging technologies such as IoT, AI, and machine learning in electronic products.</li><li>Ensure adherence to industry standards (e.g., IEEE, IPC) and regulatory requirements (e.g., FCC, CE).</li><li>Perform resource planning and prioritization for required activities.</li><li>Accountable for delivering NPD projects on-time and on-budget.</li><li>Collaborate with product managers, mechanical teams, software developers, and system architects to integrate electronics into end products.</li></ul> Requirements: <ul><li>Graduate or postgraduate (BE or M.Tech) in Electronics engineering or related engineering discipline.</li><li>12+ years of engineering experience and with more than 5 years of experience in supervising and leading engineering team.</li><li>Experience in developing and industrializing electronic and sensor products, preferably associated with Energy market.</li><li>Excellent in people and resource management.</li></ul>

Role Description: <ul><li>Job Summary The Operations Supervisor is responsible for overseeing solid dosage pharmaceutical manufacturing and packaging activities during 2nd shift operations, 3:15pm to 11:45pm.&nbsp;</li><li>This role ensures that all production operations comply with cGMP, safety standards, and production schedules.</li><li>The operations supervisor will lead and support a team of leads and operators ensuring high quality output, operational efficiency, and a safe working environment.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Oversees and coordinates Manufacturing and Packaging operations.&nbsp;</li></ul> Responsibilities: Key Accountabilities: <ul><li>Accountability Lead and supervise operations in solid dosage manufacturing and packaging to ensure adherence to Master Formula and Master Packaging Records, SOP’s, and regulatory requirements (FDA, etc.).</li><li>Communicate with department leadership, set the shift schedule, and conduct shift huddle/communication at start of shift to ensure effective communication between shifts.</li><li>Ensure timely execution of production schedules.</li><li>Monitors manufacturing and packaging processes to ensure schedule is met within standards.</li><li>Review and complete shift documentation, including batch documentation, logbooks, etc.</li><li>Coordinate with Engineering and Quality Assurance to address any equipment issues that occur during the shift Support investigations for deviations that occur during the shift.</li><li>Assist in determining and implementing CAPA.</li><li>Provide training, guidance, and performance feedback for shift employees.</li><li>Ensure training requirements are met.</li><li>Support employee development and cross-training.</li><li>Executes procedures to complete tasks in a compliant and safe manner.</li></ul> Continuous Improvement <ul><li>Captures and reports metrics; troubleshoots downtime to increase operational efficiency.</li><li>Lead or participate in Continuous Improvement projects.</li><li>Troubleshoots and resolves process issues.</li></ul> Issues &amp; Deviations <ul><li>Performs defect evaluations and initiates production events.</li><li>Identifies, reports, and suggests resolutions for processing related issues.&nbsp;</li><li>Assists in the investigation of unplanned deviations.</li></ul> Teamwork and Collaboration <ul><li>Provides priorities for the off-shift operations, focusing resources on priority products.</li><li>Interfaces with supervisors and/or Quality personnel to inform of deviations or other line issues.</li><li>Continuous Training Ensures personnel are current with training requirements.</li><li>Stays current on SOPs and cGMPs.</li><li>Continuous Safety &amp; Compliance Contribute to safety audits.</li><li>Ensures out manufacturing/packaging activities safely, as required, on a daily basis.</li><li>Follows all safety and compliance procedures and participates in required training.</li><li>Adheres to all cGMP compliance/regulatory mandates and quality requirements.</li><li>Participate in safety teams, start-up discussions, incident debriefs, etc.</li><li>Ensures compliance with SOPs, Policies and Procedures as required by the Company and regulatory agencies.</li><li>Misc Other related duties as assigned to meet departmental and Company objectives.&nbsp;</li></ul> Requirements: Qualifications Education &amp; Experience: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job Bachelor’s degree in pharmacy, Chemistry, Engineering, or a related discipline preferred, relevant experience my substitute.</li><li>Minimum of 3 years supervisory experience in pharmaceutical solid dosage manufacturing/packaging.&nbsp;</li><li>Knowledge Proficiency in a body of information required for the job e.g.</li><li>Knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Thorough knowledge of cGMP and FDA regulations.</li><li>Thorough knowledge of manufacturing and packaging operations.&nbsp;</li></ul> Skills &amp; Abilities: <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Demonstrated leadership, communication, and decision-making skills.</li><li>Ability to oversee and manage the daily operations of manufacturing and packaging. Ability to monitors processes to ensure schedule is met within standards.</li><li>Ability to analyze metrics and troubleshoot downtime.&nbsp;</li><li>Effectively interfaces with Quality Assurance to inform of deviations or other line issues.</li><li>Demonstrates the ability to work in collaboration with others as a part of a team.</li><li>Ability to lead in Continuous Improvement projects.</li><li>Possess technical writing skills.&nbsp;</li><li>Physical Requirements Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Must be able to stand for long periods of time (8- or 12-hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.</li></ul>

Role Description: <ul><li>A concise overview of the job The Supervisor, Quality Control is responsible for overseeing the day-to-day operations of the QC raw material testing group.</li><li>Supervision and enforcing cGMP’s, GLP’s, conducting investigations, method transfers, verifications of compendia methods and training of new employees.</li><li>All incumbents are responsible for following applicable Division &amp; Company policies and procedures.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Supervisory responsibilities within a single site.</li></ul> Responsibilities: <ul><li>QC Lab Management- Supervise day-to-day operations of QC Laboratory to ensure that cGMP’s, GLP’s and all other applicable compendial requirements are met.</li><li>Ensure that the testing is done as per the approved monograph procedures, investigate and take corrective actions, document investigation findings and coordinate the approval process of investigations.</li><li>Interact with Planning, Purchasing, Supply Chain, Production, QA for timely release of raw materials, excipient and packaging components.</li><li>Coordinate Analytical Methods Transfer projects. Identify and implement procedures to reduce cost of goods.</li><li>Develop systems and processes for proactive management of laboratory logistics and instrumentation.</li><li>Oversee ordering of lab supplies in observance of Departmental Budget constraints.</li><li>Workload Management- Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li><li>SOPs - Review/update SOP’s, procedures and monographs for the QC Group as needed.</li><li>Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.</li><li>Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.</li><li>Staff Development-Evaluate potential candidates for QC; performance evaluation of direct reports.</li><li>Provide training in all procedures/instrumentation/techniques, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing. 15% Total	100% Qualifications&nbsp;</li></ul> Requirements: Education &amp; Experience <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>BS in chemistry or related discipline with 10+ years’ experience in pharmaceutical testing OR MS in Chemistry or related discipline with 7+ years’ experience in pharmaceutical testing.</li><li>3+ years’ QC lab supervisory experience in pharmaceutical industry.</li><li>Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge&nbsp; <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Expert knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or SDS.</li><li>Strong knowledge and proficiency required with laboratory techniques/instruments, such as HPLC, GC, analytical balance, pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, etc.</li><li>Strong knowledge and proficiency preferred with Empower, Track Wise and Labware LIMS.</li></ul> Skills &amp; Abilities	 <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support- Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People- Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li></ul> Physical Requirements	 <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Employee is frequently required to use hands to handle or feel.</li><li>The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision.</li><li>The noise level in the work environment is usually moderate.</li><li>The work environment is representative of a group laboratory environment.</li><li>QC Lab Management, Workload Management, SOPs, Staff Development</li></ul>

Responsibilities:The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.May participate in investigations.Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses.Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeepingCleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.Under close supervision, learns to troubleshoot basic instrument problems.With guidance, participates in OOS/OOT/NOE and other investigations.Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor.May assist in drafting, editing, and reviewing SOPs and laboratory investigations.Maintains assigned training records current and in-compliance.May assist in the training of less senior laboratory staff.Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.Follows internal processes related to controlled substances continuous.Follows EH&S procedures to ensure a safe work environment.Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous.Requirements:Minimal acceptable level of education, work experience and certifications required for the job.Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required. Some pharmaceutical laboratory experience preferred.Proficiency in a body of information required for the job.e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Basic knowledge of wet chemistry techniques.Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.Competency in Microsoft Office Suite.Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.Ability to display and analyze data in a logical manner.Good verbal and written communication skills as well as good computer skills.Attention to details and accurate record keeping.Establish and maintain cooperative working relationships with othersSolid organizational skills.Ability to take initiative, set priorities and follow through on assignments.Physical & mental requirements e.g., lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicalsMust occasionally lift and/or move up to 15-25 lbs.Ability to wear personal protective equipment, including respirators, gloves, etc. Specific visions abilities are required by this job include close vision and color vision.Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.

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10 iot 40 Jobs found

Product Manager

Project Management Engineer

Product & Business Development Manager (Pharma)- Hospital Care / Women’s Health

Cyber Security Sales Specialist

Site Investigation Lead, Quality Assurance

Product Manager & Business Development Manager (Pharma)

Manager I R&D/Product DVL Engineering - Electronic and Sensor Integration

Operations Supervisor

Quality Control Supervisor

QC Chemist I

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10 iot 40 Jobs found

Product Manager

Project Management Engineer

Product & Business Development Manager (Pharma)- Hospital Care / Women’s Health

Cyber Security Sales Specialist

Site Investigation Lead, Quality Assurance

Product Manager & Business Development Manager (Pharma)

Manager I R&D/Product DVL Engineering - Electronic and Sensor Integration

Operations Supervisor

Quality Control Supervisor

QC Chemist I

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.