Research Associate – II Nitrosamines

Manager – ADL GMP

Product Manager

Reference Standard Coordinator

Regional Employee Relations Manager

Industrial Sales Engineer

F&B sales Engineer

Manufacturing Engineer

Buyer II

Job Overview: <ul><li>The Research Associate – II – Nitrosamines is responsible for conducting analytical research, method development, and risk assessment activities focused on nitrosamine impurities in pharmaceutical products.&nbsp;</li><li>The role supports regulatory compliance, safety assessment, and mitigation strategies in line with global regulatory requirements (such as those from the FDA, EMA, WHO, and ICH M7). This position requires a strong understanding of organic chemistry, analytical instrumentation, and impurity profiling.</li></ul> Responsibilities: <ul><li>Development, validation, and transfer of LC/MS methods for quantitative determination of Nitrosamine impurities (Small Molecules and NDSRIs) at ppm to sub-ppb levels</li><li>Design and execution of experiments to identify root causes of Nitrosamine formation and develop mitigation strategies</li><li>Perform chemical extractions of container closure systems and drug product solutions</li><li>Utilize advanced mass spectrometry techniques (LC-MS and GC-MS) for identification and quantification of Nitrosamines</li><li>Prepare technical reports and support documentation for regulatory filings</li><li>Collaborate with subject matter experts, supervisors, and cross-functional teams</li><li>Interpret analytical data, evaluate results, and incorporate findings into project goals</li><li>Maintain compliance with relevant Quality System Regulations and GxP standards</li></ul> Requirements: <ul><li>Experience: 6–10 years in analytical chemistry focused on Nitrosamines</li><li>Education: Master’s degree or equivalent experience; PhD preferred with relevant experience</li><li>Skills Required:</li><li>Proficiency in LCMS/GCMS instrumentation and troubleshooting</li><li>Strong knowledge of Nitrosamine chemistry and analytical techniques</li><li>Experience in method development, validation, and regulatory reporting</li><li>Ability to analyze complex data and draw meaningful conclusions</li><li>Good documentation and technical report writing skills</li></ul>

Role Description: <ul><li>The Manager –ADL, GM P is responsible for leading analytical development activities within a GMP-regulated environment, ensuring robust method development, validation, and transfer for pharmaceutical products.</li><li>This role plays a critical part in supporting product development, regulatory submissions, and commercial manufacturing by providing accurate and compliant analytical data.</li></ul> Responsibilities <ul><li>Lead and manage a team involved in method validation, method transfer, and postproduction studies (Freeze Thaw analysis, Photostability studies, Dilution studies, RLD Characterization, etc.) for 505b(2) and generic ANDAs.</li><li>Troubleshoot and resolve challenges during method validation and method transfer of new products from R&amp;D to manufacturing sites.</li><li>Support regulatory filings and respond to analytical function queries.</li><li>Ensure compliance with cGLP within the ADL GMP function.</li><li>Provide support during quality inspections by regulatory agencies at manufacturing plants.</li><li>Timely closure of LIR, NCR, CCN, CAPA and ensure implementation of corrective and preventive actions.</li><li>Ensure timely compliance with Pharmacopoeia updates.</li><li>Mentor, coach, and develop team members for task execution and personal growth.</li><li>Collaborate with external partners (CRO/CMO) for analytical testing execution.</li><li>Work cross-functionally with project management, regulatory affairs, formulation development, manufacturing, and quality control teams.</li></ul> Requirements: <ul><li>Education: Ph.D. OR MPharm.</li><li>Experience: 3–4 years of team handling experience.</li></ul> Skills Required: <ul><li>Strong knowledge of analytical method validation, method transfer, Pharmacopoeia compliance, cGLP, and documentation practices.</li><li>Sound understanding of analytical techniques with good learning agility.</li><li>Excellent technical writing and computer skills for data recording, protocol/report generation, and presentations.</li><li>Strong coordination, relationship management, and ability to work in multicultural teams.</li><li>Effective communication and team management skills.</li><li>Knowledge of latest quality and regulatory requirements.</li><li>Ability to delegate effectively and take autonomous decisions.</li><li>Critical thinking skills for problem-solving and decision making.</li></ul>

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: Sample Management <ul><li>Performs QC reference standard/chromatographic column receipt, processing, distribution for testing and storage.</li><li>Performs QC reference standard reconciliation and disposal.</li><li>Tracks inventory of reference standards in the lab.</li><li>Uses laboratory software for reference standard, chromatographic column management.</li><li>Verifies accuracy of labeling/documentation provided with reference standards.</li><li>Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.</li><li>Coordinates, with lab management, in-house qualification of reference standards. Submit samples to the appropriate lab groups for testing.</li><li>Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.</li><li>Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.</li><li>Uses the purchasing system to procure reference standards and laboratory supplies.</li><li>Provide status updates to QC management and other departments regarding the status of reference standard inventory.</li><li>Maintain a safe work environment by following standards and procedures and complying with legal regulations.</li></ul> Lab Equipment <ul><li>Maintains, operates equipment and instruments supporting reference standard processing.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative. maintenance, reference standard/sample receiving, chemical inventory, document filing and housekeeping.</li><li>Works with internal resources to maintain lab in an optimal state. 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></ul> Investigations <ul><li>Escalates any trends/events to the QC Lab Manager.</li><li>Escalates any reference standard documentation issues to the QC Lab Manager.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Assists, as and when needed, scientists working in the laboratory.</li><li>May assist in drafting, editing, and reviewing SOPs.</li></ul> Training <ul><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of laboratory staff.</li></ul> Compliance <ul><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.</li><li>Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances.	continuous.</li></ul> Safety <ul><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: Education &amp; Experience <ul><li>College graduate, preferably in a Science related field.</li><li>Laboratory experience related to sample management preferred.</li></ul> Knowledge <ul><li>Basic knowledge of reference standard/sample management in a laboratory environment.</li><li>Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><li>Proficiency with computers.</li></ul> Skills &amp; Abilities <ul><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></ul> Physical Requirements	 <ul><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.</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>Lead and manage employee relations activities within the IMEA region, ensuring timely and fair case resolution in alignment with global ER policies and practices.</li><li>Provide direct ER leadership over the India business in particular, as the largest business in the region.</li><li>Support labor/industrial relations strategy across the region, including union engagement, worker committee processes, and required consultation protocols under local law.</li><li>Serve as the primary escalation point for complex and high-risk ER cases, partnering with Legal and other stakeholders as needed.</li><li>Directly manage ER case intake, investigation, resolution, and closure, ensuring a consistent, professional colleague experience across the region.</li><li>Partner with regional Business-Facing HR teams to deliver hybrid ER support where needed, especially in countries with minimal headcount or unique legal complexity.</li><li>Provide day-to-day direction and mentorship to regional ER Advisors, ensuring professional service delivery, skill development, and workload balance.</li><li>Monitor case trends, emerging risks, and workforce issues, delivering actionable insights and recommendations to regional and global leadership.</li><li>Execute the Employee Relations annual governance cycle within the region, including quarterly campaign delivery, stakeholder reporting, and process audits.</li><li>Ensure full adoption of ER case management protocols in ServiceNow, including accurate logging, escalation, documentation, and timely case closure.</li><li>Deliver coaching and education to site leaders on performance management, conflict resolution, workplace expectations, and policy application.</li><li>Collaborate on global ER projects and initiatives, bringing IMEA-specific insights to shape global practices, policies, and processes.</li><li>Support leaders to foster a fair, consistent, and compliant employee experience aligned with our client People Plan.</li></ul> Requirements: <ul><li>Education: Bachelor’s degree in Human Resources, Business Administration, or a related field; Master’s degree preferred.</li></ul> Experience: <ul><li>7+ years of experience in employee relations or HR, including regional or global support experience.</li><li>5+ years of employee relations or HR experience in India</li><li>3+ years managing complex employee relations cases required.</li><li>Experience working in a centralized Employee Relations delivery model preferred.</li></ul> Skills:&nbsp; <ul><li>Strong leadership and delegation skills, excellent problem-solving and conflict resolution skills, team leadership experience, and expertise in handling escalated cases and performance improvement processes.</li><li>Proficiency in English and Marathi required; additional languages based on region are a plus (e.g., Arabic, Hindi, French).</li></ul>

Responsibilities: <ul><li>Conduct market research to identify potential customers in the Industrial Sector in North India.</li><li>Develop and implement targeted marketing strategies to reach potential customers in these sectors.</li><li>Key account management including End Users, OEMs &amp; System Integrators</li><li>Build long-term customer business relations right from concept phase and ensure product standardization at customer sites.</li><li>Build and maintain relationships with existing customers in these sectors, identifying opportunities for cross-selling and upselling.</li><li>Attend industry events and exhibitions to showcase company products and engage with potential customers.</li><li>Provide technical expertise and assistance to customers, helping them to select the most suitable equipment for their specific applications in these sectors.</li><li>Act as the customers advocate and ensure their technical needs are met.&nbsp;</li><li>Work closely with the company product development team to identify and develop new products that meet the specific needs of the Process Industries in India.</li><li>Produce and maintain detailed documentation on all customer interactions, including project timelines, equipment specifications, and budget constraints.</li><li>Provide ongoing technical support and guidance to other departments within the company as required to ensure that all customers receive the highest level of service and support.</li><li>Provide high-quality technical support to prospects and customers during pre- and post-sales situations.&nbsp;</li><li>Understand and solve challenging application problems by recommending appropriate company solutions.&nbsp;</li><li>Update records in CRM interface for opportunity pipeline, appointments, lead and present business analytical data through CRM&nbsp;</li></ul> Requirements:﻿ <ul><li>Hold relevant Diploma Mechanical / Bachelor of Engineering, Qualifications and a strong business background.</li><li>Preferably have at least 10 -15 years of experience in the Fluid Handling Industrial, with a specific focus on pumps used in Process Industry applications.</li><li>Possess excellent written and spoken English communication skills.</li></ul>

Responsibilities: <ul><li>Region coverage South India (Andhra Pradesh / Telangana /Karnataka / Tamil Nadu / Kerala).&nbsp;</li><li>Conduct market research to identify potential customers in the F&amp;B&amp;S Sector in South India.</li><li>Develop and implement targeted marketing strategies to reach potential customers in these sectors.</li><li>Key account management including End Users, OEMs &amp; System Integrators</li><li>Build long-term customer business relations right from the concept phase and ensure product standardization at customer sites.</li><li>Build and maintain relationships with existing customers in these sectors, identifying opportunities for cross-selling and upselling.</li><li>Attend industry events and exhibitions to showcase company products and engage with potential customers.</li><li>Provide technical expertise and assistance to customers, helping them to select the most suitable equipment for their specific applications in these sectors.</li><li>Act as the customers advocate and ensure their technical needs are met.&nbsp;</li><li>Work closely with the company product development team to identify and develop new products that meet the specific needs of the PI - F&amp;B&amp;S in India.</li><li>Produce and maintain detailed documentation on all customer interactions, including project timelines, equipment specifications, and budget constraints.</li><li>Provide ongoing technical support and guidance to other departments within the company as required to ensure that all customers receive the highest level of service and support.</li><li>Provide high-quality technical support to prospects and customers during pre- and post-sales situations.&nbsp;</li><li>Understand and solve challenging application problems by recommending appropriate company solutions.&nbsp;</li><li>Update records in CRM interface for opportunity pipeline, appointments, lead and present business analytical data through CRM&nbsp;</li></ul> Requirements: <ul><li>Hold relevant Diploma Mechanical / Bachelor of Engineering, Qualifications and a strong business background.</li><li>Preferably have at least 10 -15 years of experience in the Fluid Handling Industry.&nbsp;</li><li>Possess excellent written and spoken English communication skills.</li></ul>

Responsibilities: <ul><li>Conduct market research to identify potential customers in the Industrial Sector in North India.</li><li>Develop and implement targeted marketing strategies to reach potential customers in these sectors.</li><li>Key account management including End Users, OEMs &amp; System Integrators</li><li>Build long-term customer business relations right from concept phase and ensure product standardization at customer sites.</li><li>Build and maintain relationships with existing customers in these sectors, identifying opportunities for cross-selling and upselling.</li><li>Attend industry events and exhibitions to showcase company products and engage with potential customers.</li><li>Provide technical expertise and assistance to customers, helping them to select the most suitable equipment for their specific applications in these sectors.</li><li>Act as the customers advocate and ensure their technical needs are met.&nbsp;</li><li>Work closely with the company product development team to identify and develop new products that meet the specific needs of the Process Industries in India.</li><li>Produce and maintain detailed documentation on all customer interactions, including project timelines, equipment specifications, and budget constraints.</li><li>Provide ongoing technical support and guidance to other departments within the company as required to ensure that all customers receive the highest level of service and support.</li><li>Provide high-quality technical support to prospects and customers during pre- and post-sales situations.&nbsp;</li><li>Understand and solve challenging application problems by recommending appropriate company solutions.&nbsp;</li><li>Update records in CRM interface for opportunity pipeline, appointments, lead and present business analytical data through CRM&nbsp;</li></ul> Requirements: <ul><li>Hold relevant Diploma Mechanical / Bachelor of Engineering, Qualifications and a strong business background.</li><li>Preferably have at least 10 -15 years of experience in the Fluid Handling Industrial, with a specific focus on pumps used in Process Industry applications.</li><li>Possess excellent written and spoken English communication skills.</li></ul>

Responsibilities: <ul><li>Develop, implement, and optimize manufacturing processes to improve efficiency, quality, and cost-effectiveness.</li><li>Provide technical support for new product introduction (NPI), including process design, tooling, and equipment validation.</li><li>Conduct root cause analysis and lead corrective/preventive actions (CAPA) to&nbsp;</li><li>resolve production issues.</li><li>Collaborate with cross-functional teams (R&amp;D, Quality, Supply Chain, Maintenance) to ensure smooth project execution and production readiness.</li><li>Prepare and maintain process documentation, work instructions, and training materials.</li><li>Monitor key production metrics (yield, scrap, cycle time, downtime) and implement continuous improvement initiatives.</li><li>Participate in lean manufacturing, Six Sigma, and Kaizen activities to drive operational excellence.</li><li>Ensure compliance with safety standards, environmental regulations, and ISO/IATF quality system requirements.</li><li>Support cost reduction projects through process improvement, automation, and supplier collaboration.</li></ul> Requirements: <ul><li>Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field.</li><li>3–5 years of relevant experience in manufacturing engineering; automotive or electronics industry experience preferred.</li><li>Strong knowledge of manufacturing processes such as machining, assembly, injection molding, stamping, or PCB assembly (depending on industry).</li><li>Familiarity with APQP, PPAP, FMEA, Control Plan, and other quality tools.</li><li>Proficiency in CAD software (e.g., AutoCAD, SolidWorks, Creo) and MS Office.</li><li>Hands-on experience with Lean Manufacturing and problem-solving methodologies (5Why, 8D, DMAIC).</li><li>Good communication and coordination skills; able to work in cross-functional and multicultural teams.</li><li>English: able to read and write technical documents; spoken English is a plus.</li></ul>

Responsibilities: <ul><li>Support migration of Indirect Procurement processes from other Global countries to Alabang and prepare Indirect Procurement related process documentation (process maps and work instructions)</li><li>Become a Subject Matter Expert for Indirect Procurement related topics</li><li>Handle and resolve escalated procurement processing issues</li><li>Answer and resolve suppliers, stakeholders and AP queries to ensure timely resolution</li><li>Maintain supplier master data information in relevant systems</li><li>Ensure proper processing of PR’s and PO’s</li><li>Perform compliance checks</li><li>Expedite POs</li><li>Answer tickets (Procurement Helpdesk)</li><li>Manage invoice pricing issues</li><li>Create, maintain Info Record &amp; source lists</li><li>Spot Buy / Requisition Based Sourcing</li><li>Execute all procurement activities in-scope</li><li>Prepare and process eRFQ’s</li><li>Smaller Contract (value/complexity) negotiation &amp; execution</li><li>Execution of Projects assigned by Commodity Management</li><li>Desk Research and Price Comparison</li><li>Supplier training on tools</li><li>End-user Trainings</li><li>Savings reporting</li><li>Maintain communication with suppliers, stakeholders and other Indirect Procurement members</li><li>Execute periodically PR/PO audit queries or upon request KPI’s measurements</li><li>Ensure compliance with applicable client policies</li><li>Contribute to continuous improvement initiatives within the function, ensuring that improvements are incorporated in the work routine</li><li>Support robust compliance environment with applicable policies, procedures and processes</li><li>Build relationship with key stakeholders including suppliers</li><li>Support local BU owners, Function representatives or other Procurement team members to solve issues in a timely manner,</li><li>Build strong relationship with key stakeholders,</li><li>Attend team meetings and trainings as required.</li></ul> Requirements: <ul><li>Good Experience in Indirect Procurement (5+ years)</li><li>Previous experience in shared service environment</li><li>Good of MS office; very good Excel and other relevant tools for the function</li><li>SAP PR2, S/4</li><li>Good communication skills</li><li>Very good English language skills in speech and writing + additional language on top of Filipino preferred (Chinese, Spanish, German, French, etc.)</li><li>Diversified Industrial Products/Manufacturing industry experience preferred</li><li>Good command of other languages is a very important asset</li><li>Experience in a procurement shared service center supporting multiple countries / business units</li><li>Experience working for a Manufacturing company preferred</li><li>Good understanding of end-to-end S2P processes and associated technology platforms</li><li>Excellent organizational and analytical skills, solid problem solving and detail oriented</li><li>Strong communication skills</li><li>Ability to work with deadlines</li><li>Ability to work in culturally diverse teams with many levels of personnel.</li></ul>

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68 documentation Jobs found

Research Associate – II Nitrosamines

Manager – ADL GMP

Product Manager

Reference Standard Coordinator

Regional Employee Relations Manager

Industrial Sales Engineer

F&B sales Engineer

Industrial Sales Engineer

Manufacturing Engineer

Buyer II

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68 documentation Jobs found

Research Associate – II Nitrosamines

Manager – ADL GMP

Product Manager

Reference Standard Coordinator

Regional Employee Relations Manager

Industrial Sales Engineer

F&B sales Engineer

Industrial Sales Engineer

Manufacturing Engineer

Buyer II

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

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Contact Us

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