Innovation Lead/ Research Scientist II

Chief Sustainability Officer

Senior Manager - Characterization R&D - Extractables & Leachables

Supply Chain Manager

Manufacturing Operator III

Chemist III

Analytical Scientist II

QC Chemist I

Reliability Technician-Packaging

Sr Director of QA

Responsibilities: <ul><li>Apply specialized scientific knowledge in creative ways to develop new innovative pharmaceutical products/processes.&nbsp;</li><li>Independently plan, execute and manage projects, incorporating advanced theories, methods and technologies in multiple disciplines to generate innovative solutions to complex problems where little clear precedence exists.</li><li>Leverage input from colleagues in R&amp;D and other functions e.g. Commercial, Clinical, Legal, and Manufacturing to create innovative products/processes/methods through novel combinations of expertise within the organization.&nbsp;</li><li>Incorporate knowledge of customer use and product design to predict product effectiveness/anticipate potential failures.&nbsp;</li><li>Analyze executed designs and results and modify them to increase product/process acceptance, quality and reliability.</li><li>Identify opportunities for our intellectual property and work with Legal counsel to file patents.&nbsp;</li><li>Present research results at external conferences and publish articles in peer-reviewed scientific journals as appropriate.&nbsp;</li><li>Supervise and direct the laboratory work for a small team of lower level formulation and analytical scientists to facilitate rapid assessment of novel product formulation concepts, leveraging right first time/fail fast approach to evaluate and recommend promising product candidates to enter our product development process.</li><li>Sought out by other teams and individuals to offer technical advice; may act as coach, mentor, supervisor and technical advisor to junior members within the discipline.</li></ul> Requirements: <ul><li>To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.&nbsp;</li><li>Must possess strong knowledge of pharmaceutical formulation science and solid knowledge of related disciplines, plus knowledge of quality and general business systems.</li><li>Possess an in-depth knowledge and understanding of GxP and related regulations and guidance, and ability to leverage for efficient product design</li><li>Must possess strong ability to negotiate for resources and influence others internally and externally.</li><li>Must be able to challenge the status quo.</li><li>Must be able to contribute in setting strategic scientific direction for the organization and communicate the vision to his/her team members.&nbsp;</li><li>Can comfortably handle risk and uncertainty; can decide and act without having the total picture.</li></ul> Education and/or Experience: <ul><li>Include the education and/or experience that is necessary to perform the job satisfactorily.</li><li>Bachelors degree in a scientific discipline with at least 15 years of relevant experience, MS with at least 10 years, or PhD with at least 3-4 years of relevant experience.&nbsp;</li><li>QSR research experience is essential and GMP experience useful.</li><li>Lab experience includes research and/or development in GMP/QSR environment, leadership of technical teams, and technical leadership of drug product development programs.&nbsp;</li><li>Project management experience is desirable.</li></ul>

This leading Pharma company are not just in the business of pharmaceuticals; they are committed to making a positive impact on the world through operations, innovations, and collaborations. As the Chief Sustainability Officer, you will play a pivotal role in shaping and executing our sustainability strategy, ensuring that sustainability is at the core of everything they do. Why This Organisation?•	Global Influence, Local Impact: With a presence in over 100 countries, they have the scale to make a significant global impact while understanding and addressing local sustainability challenges.•	Innovation for Good: They believe that innovation can drive positive change. As the Chief Sustainability Officer, you will have the opportunity to lead initiatives that leverage cutting-edge technologies and approaches to create a more sustainable future.•	Collaborative Culture: They foster a collaborative and inclusive culture that values diverse perspectives. You will work with cross-functional teams and stakeholders to drive sustainability across all aspects of the business. Your Role and Responsibilities:•	Sustainability Strategy: Develop and lead our sustainability strategy, setting ambitious yet achievable goals that encompass environmental, social, and governance aspects.•	Stakeholder Engagement: Collaborate with internal and external stakeholders, including regulatory bodies, NGOs, and industry associations, to drive collective sustainability efforts.•	Innovation and Impact: Identify and implement innovative solutions that minimize our environmental footprint, improve our social contributions, and enhance our long-term value.•	Reporting and Transparency: Ensure transparent and accurate reporting of our sustainability progress, aligning with global standards and best practices.•	Risk Management: Evaluate potential risks and opportunities related to sustainability trends, regulations, and stakeholder expectations. Qualifications and Skills:•	Proven experience in a senior sustainability leadership role, preferably within the pharmaceutical or healthcare industry.•	Deep understanding of sustainability trends, frameworks, and best practices.•	Exceptional communication skills to engage and inspire stakeholders at all levels.•	Track record of successfully driving sustainability initiatives that deliver tangible results.•	Strong strategic thinking, analytical, and problem-solving skills.

Responsibilities: <ul><li>Sr. Manager, R&amp;D characterization is responsible for contributing to all phases of Extractable &amp; Leachable studies carried out IH and at CROs. This would include study design as sample preparation, analysis, and data interpretation.</li><li>Independently or with support of sub department manager, author and contribute to the experimental protocols, process and interpret data, author technical reports in English.</li><li>Ensure technical output of the team is of the highest quality, scientifically sound and appropriately addresses the business need.</li><li>Ensure compliance in all research, data collection and reporting activities.</li><li>Supervise and direct the lab work for junior level executives.</li><li>Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.</li><li>Support the build out of the R&amp;D- E&amp;L laboratory.</li><li>Develop and enhance technical capability through training and on job experience.</li><li>Ensure laboratory is equipped with instrumentation that is qualified to appropriate standards, maintained in a functional state and aligns with the business needs.</li><li>Key contributor during experimental study designs, execution and review/approval at IH &amp; CROs study.</li><li>Competent in interpreting complex analytical data and presenting in a form that is suitable for a wide-ranging audience</li><li>Collaborate with a multidisciplinary team of subject matter experts to generate innovative solutions to complex problems through the use of multiple disciplines and technical principles.</li><li>Create innovative products/processes/methods through novel combinations of expertise within the organization.</li><li>Contribute to the long-term scientific strategy of the department.</li><li>Influence the regional external regulatory environment in the areas of Extractables &amp; Leachables,</li><li>Elemental Impurities, and Structure Elucidation.</li><li>Write technical reports and documenting development work.</li></ul> Requirements: <ul><li>15+ years of experience in Extractables &amp; Leachables R&amp;D.</li><li>The candidate needs to have strong exposure in dealing with complex E&amp;L Case studies.</li><li>Should have experience managing and leading teams.</li><li>Should hold a PhD, Masters or equivalent with strong exposure to the chemistry side of pharmaceuticals.</li></ul>

Responsibilities: <ul><li>Responsibilities include assess supply chain status of products, planning/executing goods movements (production and inbound goods) also ensuring completeness and accuracy of SAP data.</li><li>Participate in the review/confirmation of the demand forecast; assess inventory level of all finished goods based on the demand forecast; oversee and/or validate inventory planning at the manufacturing sites.</li><li>Work closely with the 3PL to ensure timely receipt of shipments.</li><li>Mediate the resolution of any delays in having product available for sale</li><li>Prepare monthly inventory report, analyze and highlight projected inventory concerns based on Supply Plan.</li><li>Act as a contact for any planning/inventory availability issues with the plant manufacturing and supply team.</li><li>Provide oversight on all relevant product launch activities, and effectively manage internal and external stakeholders to ensure alignment on resource requirements.</li><li>Routinely collaborate with department head to achieve cross company alignment with respect to product supply risk and upside, inventory management through all downstream nodes Ensure continuity of supply for all products</li><li>Analyze and manage adequate inventory levels per guidelines, provide internal stake holders analysis of low and excess inventory items</li><li>Create, manage, and facilitate regular meetings, including the development of agendas, issue written minutes, and follow up on action items</li><li>Provide logistics support, as needed, including coordination and prioritization of planned shipments as well as shipment tracking</li><li>Inventory management and Logistics tracking including coordination with brokers for relevant deliveries.</li><li>Support data analysis for RFP’s – weekly, monthly and annual RFP’s.</li><li>Aid in analysis and review of 3 PL warehousing cost and other operational and logistical expenses.</li><li>Aid in process improvement mechanisms to enhance service level and inventory management.</li><li>Support serialization track and trace project.</li><li>Aid in process improvement mechanisms to enhance service and inventory.</li></ul> Requirements: Desired Skills: <ul><li>Highly analytical skills with strong problem solving ability utilizing minimal supervision</li><li>Excellent interpersonal skills ; team player ability to bridge strong working relationships across multiple disciplines</li><li>Ability to work in a global business culture</li><li>Excellent communication, verbal and written</li><li>Bachelor’s degree, preferably in supply chain, operations or related discipline.</li><li>Atleast 3 years of relevant experience in Supply Chain in pharmaceutical industry(preferred)</li><li>Demonstrated expertise with MS tools including Excel, Word, and Power Point. Expertise using SAP desirable.</li><li>Ability to manage large volume of spreadsheet data</li></ul>

Responsibilities: <ul><li>The Manufacturing Operator III performs functions relating to the processing of drug products, ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements and in conjunction with all Standard Operating Procedures (SOPs).&nbsp;</li><li>Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing.&nbsp;</li><li>&nbsp;Proactively identifies and resolves complex problems where considerable judgment is required in choosing among multiple options.&nbsp;</li><li>Understands and runs processes to meet the assigned standards/routers and fulfills the assigned schedule; when these are not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forward.&nbsp;</li><li>Troubleshoots process issues and, as a team member, analyzes root causes and makes recommendations.&nbsp;</li><li>Responsible for the safe and efficient execution of job duties.&nbsp;</li><li>May serve as back-up to the Senior Manufacturing Technician.</li><li>Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, dispensing, mixing, coating, encapsulating, granulating, drying, milling, blending, compressing, potent compound, etc.&nbsp;</li><li>Meets requirements for use of manufacturing equipment and other commonly used equipment per SOPs.&nbsp;</li><li>Executes written SOPs to ensure the purity of materials involved in the manufacturing process.&nbsp;</li><li>Properly uses all scales, including printouts, zeroing, setting tares, and daily calibration verification per SOPs.&nbsp;</li><li>Examines manufacturer Product ID Labels, Quality Control release tags, and Batch Production Record to verify issued/staged raw materials can be released for production.&nbsp;</li><li>Cleans manufacturing equipment and facilities according to established SOPs.&nbsp;</li><li>Executes machine change-overs from batch to batch.&nbsp;</li><li>Completes a variety of assignments independently based on established procedures.</li><li>Identifies process improvements that drive increased efficiency, throughput and quality&nbsp;</li><li>May sample batches, including validation batches, for quality testing.&nbsp;</li><li>Executes required in-process product quality checks and documents accurately.&nbsp;</li><li>Understands and runs processes to meet the assigned schedule and standards/routers; when this is not achieved, participates in the debriefing sessions to understand the reasons why and what needs to be corrected moving forward.</li><li>Completes documentation associated with manufacturing processes (e.g. batch record, protocol, and logbooks) with detail and accuracy.&nbsp;</li><li>Meets requirements for entries on all applicable Batch Production pages, completion and attachment of all dispensary and weight verification tickets.&nbsp;</li><li>Verifies the manufacturing process on BPR in an accurate and timely manner.&nbsp;</li><li>Provides status updates and operational challenges.&nbsp;</li><li>Proactively identifies and troubleshoots process issues and, as a team member, analyzes root causes and makes recommendations.&nbsp;</li><li>Typically participates in Continuous Improvement projects of a higher scope and complexity.</li><li>Carries out processing/manufacturing activities safely, as required, on a daily basis.&nbsp;</li><li>Follows all safety and compliance procedures and participates in required training.&nbsp;</li><li>Adheres to all cGMP compliance/regulatory mandates and quality requirements.&nbsp;</li><li>Participates in safety teams, start-up discussions, and incident debriefs, etc.&nbsp;</li><li>Ensures compliance with SOPs, policies and procedures as required by the Company and regulatory agencies.</li><li>Maintains a clean, organized work area.</li><li>Conforms to all training requirements, including company required and machine specific training.</li><li>May become a certified trainer and provide mentoring and training</li><li>Exhibits team work and motivates others to achieve project objectives.</li><li>Collaborates within own work unit and with those from other departments outside of work unit and/or with external vendors/suppliers.</li></ul> Requirements: <ul><li>HS diploma or equivalent at minimum, with 0-2 years’ related experience*</li><li>Forklift certification may be required for blending and granulation.</li><li>Ability to read a tape measure</li><li>Ability to demonstrate safe and effective operation of all required equipment</li><li>Applies skills and knowledge to recognize issues and to increase efficiency, throughput and quality.</li></ul>

Responsibilities: <ul><li>The Chemist III, under minimal supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.</li><li>Has demonstrated competence in conducting all types of physical and chemical analyses (including complex analyses) using all equipment. Detects, conducts, and reports on OOS/OOT/NOE and other investigations.</li><li>Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. Participates in troubleshooting analyses and instrumentation. Trains less senior staff.&nbsp;</li><li>Conducts laboratory analyses according to approved test methods: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.</li><li>Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UVVis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.</li><li>Uses laboratory software for analyses.</li><li>Reviews and approves laboratory test data and documentation for completeness and compliance.</li><li>Is alert to and detects abnormalities during performances of tests and reviews.</li><li>Elevates abnormalities to Supervisor.</li><li>Performs lab methods transfer and participate in method validation/verification studies</li><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.</li><li>Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Troubleshoots instrument/chromatography problems and identifies improvements/CAPAs&nbsp;</li><li>Detects, conducts and reports on OOS/OOT/NOE and other investigations.</li><li>Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action.</li><li>Writes, edits and reviews SOPs and laboratory investigations</li><li>Maintains assigned training records current and in-compliance</li><li>Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures&nbsp;</li><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.</li><li>Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances</li><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS</li></ul> Requirements: <ul><li>Bachelor of Science Degree in chemistry, chemical engineering or related field with 4+ years’ relevant analytical laboratory experience OR,</li><li>Master’s Degree in above disciplines with 2+ years’ relevant analytical lab experience.</li><li>Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports.</li><li>Full 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.</li><li>Thorough knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Has demonstrated competence in conducting chemical analyses.</li><li>Strong knowledge of wet chemistry techniques.</li><li>Competency in Microsoft Office Suite</li><li>Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information, reporting to management</li><li>Ability to display and analyze data in a logical manner.</li><li>Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information.</li><li>Ability to display and analyze data in a logical manner.</li><li>Strong verbal and written communication skills as well as good computer skills.</li><li>Strong attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills.</li><li>Ability to coach less senior staff and develop laboratory skills and ability.</li><li>Ability to take initiative, set priorities and follow through on assignments</li></ul>

Responsibilities: <ul><li>The Senior Scientist, Analytical R&amp;D will independently lead analytical method develop and validation activities for assigned projects, develop and validate analytical methods, review DMFs/Technical documents, identify specification requirements and set up specifications/specification justifications for raw materials and finished products, develop and understand product stability to guide design of stability studies in support of registration batches, generate technical documents to support regulatory submissions, provide timely analytical support on deficiency responses and product approval inspections.&nbsp;</li><li>Independently lead analytical method develop and validation activities for assigned ANDA products.</li><li>Develop and validate analytical methods for release and stability testing.</li><li>Review and evaluate drug substance supplier’s technical documents and provide recommendation in API vendor selection.</li><li>Identify specification requirements and set up specifications and specification justifications for raw materials and drug products.</li><li>Resolve complex problems in method or product development.</li><li>Develop and understand product stability to guide design of stability studies in support of product registration.</li><li>Generate technical documents to support regulatory submissions.</li><li>Provide timely analytical support on deficiency responses and product approval inspections.</li><li>Review laboratory notebooks, raw data and technical documentation in support of regulatory filings.</li><li>Interact with other depts: Formulations, Regulatory Affairs, Production, Strategic Sourcing, etc., to support timely new product development/submission of new ANDAs.</li><li>Peer review of lab notebooks.</li><li>Evaluate, troubleshoot/improve existing analytical methods when necessary.</li><li>Continuously update knowledge of latest technologies related to analytical science.</li><li>Work in compliance with cGMP/cGLP regulations.</li></ul> Requirements: <ul><li>PhD in scientific discipline + min. 3 yrs. in pharmaceutical analytical chemistry or related field, with hands-on knowledge of current analytical techniques OR</li><li>MS + min. 5 yrs. OR BS with 7 yrs.</li><li>Strong knowledge of analytical chemistry and concepts in developing and validating methods to meet correct pharmaceutical standards.</li><li>Superior knowledge of major analytical techniques such as HPLC/UPLC, dissolution, FT-IR, physical characterization, etc.</li><li>Strong knowledge of FDA, ICH, and USP guidance and regulations.</li></ul>

Responsibilities: <ul><li>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.</li><li>May participate in investigations.</li><li>Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.</li><li>Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.</li><li>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.&nbsp;</li><li>Uses laboratory software for analyses.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping</li><li>Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Under close supervision, learns to troubleshoot basic instrument problems.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor.</li><li>May assist in drafting, editing, and reviewing SOPs and laboratory investigations.</li><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of less senior laboratory staff.</li><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.</li><li>Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances continuous.</li><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous.</li></ul> Requirements: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job.</li><li>Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required.&nbsp;</li><li>Some pharmaceutical laboratory experience preferred.</li><li>Proficiency in a body of information required for the job.</li><li>e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>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.&nbsp;</li><li>Basic knowledge of wet chemistry techniques.</li><li>Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><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>Ability to display and analyze data in a logical manner.</li><li>Good verbal and written communication skills as well as good computer skills.</li><li>Attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others</li><li>Solid organizational skills.</li><li>Ability to take initiative, set priorities and follow through on assignments.</li><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>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 chemicals</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.&nbsp;</li><li>Specific visions abilities are required by this job include close vision and color vision.</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Responsibilities: <ul><li>Develops and applies basic knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for the position. </li><li>Focused on a limited range of activities.&nbsp;</li><li>Completes routine tasks that are typically embedded in SOPs, operational or technical work practices and guidelines. Learns to identify deviations from accepted practice or procedure.</li><li>Identifies and solves routine problems that involve direct application of skills and knowledge. Seeks the input and assistance of others.&nbsp;</li><li>Learns the responsibilities of being a team member. Participates as a team member. Collaborates primarily within the immediate work unit, which may be cross-functional.</li><li>Close supervision involving detailed instructions and requires regular checks on work performance.</li></ul> Requirements: <ul><li>HS diploma or equivalent with related certification, or HS diploma or equivalent with 2-4 years’ related experience.</li><li>Ability to use Blue Mountain for PM execution and utilization of Apple tablets to complete PMs and MSRs desired.&nbsp;</li><li>Ability to use and read test instruments.&nbsp;</li><li>Ability to learn pharmaceutical maintenance and cGMP processes.&nbsp;</li><li>Ability to learn to perform tasks and read basic schematics, technical drawings and/or blueprints.&nbsp;</li><li>Ability to learn set ups.&nbsp;</li><li>Identifies and solves routine problems that involve direct application of skills and knowledge. Seeks the input and assistance of others.</li></ul> Knowledgeable in one or more of the following areas: <ul><li>Electrical</li><li>Hydraulic</li><li>Pneumatics</li><li>Mechanical</li><li>PLCs</li><li>Basic math, writing skills, and excellent problem solving abilities.&nbsp;</li><li>Basic computer skills.&nbsp;</li><li>Ability to use hand tools safely.&nbsp;</li></ul>

Role Description: <ul><li>The Sr. Director of Quality Operations is responsible for the quality unit at the site and for oversight of all quality related activities.&nbsp;</li><li>The incumbent will be an integral member of the Site Leadership Team. The Sr.&nbsp;</li><li>Director is accountable to ensure that the systems, procedures and practices for pharmaceutical operations at the site comply with policies and the cGMP requirements of all major regulatory agencies that regulate the site (e.g. FDA/EMA, etc.).</li></ul> Responsibilities: <ul><li>Leads and oversees Quality Assurance, Quality Control, Stability and related site quality activities, including commercial and development products.</li><li>Quality Lead for regulatory inspections, client audits and the site internal and external audit program. Prepares and approves responses to all external audit findings and oversees direct implementation of corrective and preventative actions (CAPAs).</li><li>Manages the QC team to ensure the availability of materials and testing necessary to meet the scheduled production and the site’s monthly target numbers.</li><li>Directs the QA team to ensure the timely completion of investigations, batch record reviews and batch releases to meet the site’s monthly targeted delivery performance.</li><li>Co-leads the Site Quality Council with Site Head and manages monthly meeting.</li><li>Contributes to the review and implementation of quality agreements with clients, contractors, and suppliers.</li><li>Provides direction on state of quality, quality related issues and quality metrics for the site. Independently identifies and initiates functional and cross-functional projects/task teams on a pre-emptive or as needed basis.</li><li>Identifies and implements various strategic initiatives that drive cost control and cost reductions. Responsible for development of the Quality Unit budget and successful execution to achieve it.</li><li>Review and/or approve deviations, out-of-specification reports, formal investigations, complaint investigations; Corrective Action/Preventative Action (CAPA) program and other reports as necessary.</li><li>Oversees the Quality training team on GMP related employee and contractor training. Ensures the training program adequately provides the guidance, procedures, systems and documentation that demonstrates personnel have the experience and qualifications to perform their job.</li><li>Interfaces with the regulatory team to evaluate product changes and new product introductions at the site to ensure compliance.</li><li>Coaches, councils and mentors staff on job related activities and career development.</li><li>Evaluates quality staffing needs with major fluctuations in production volumes and growth opportunities with technical transfer and development projects. Provides adequate justifications for resources when applicable.</li></ul> Requirements: <ul><li>Bachelor’s degree in the physical sciences or engineering. MS or Ph.D. in scientific or healthcare discipline preferred, but not required.</li><li>15+ years of Pharmaceutical QA and QC experience, with demonstrated growth in responsibilities and expertise.</li><li>7+ years of experience managing all aspects of a Quality department and function.</li><li>Proven leadership and development of a staff of quality professionals.</li><li>Detailed knowledge of chemistry and manufacturing/packaging controls.</li><li>Extensive knowledge of cGMP requirements (21CFR Part 211 and/or ICH Q7).</li></ul>

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37 pharmaceuticals Jobs found

Innovation Lead/ Research Scientist II

Chief Sustainability Officer

Senior Manager - Characterization R&D - Extractables & Leachables

Supply Chain Manager

Manufacturing Operator III

Chemist III

Analytical Scientist II

QC Chemist I

Reliability Technician-Packaging

Sr Director of QA

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37 pharmaceuticals Jobs found

Innovation Lead/ Research Scientist II

Chief Sustainability Officer

Senior Manager - Characterization R&D - Extractables & Leachables

Supply Chain Manager

Manufacturing Operator III

Chemist III

Analytical Scientist II

QC Chemist I

Reliability Technician-Packaging

Sr Director of QA

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