Merck
Associate Principal Scientist, Analytical R&D
Merck, Durham, North Carolina, United States, 27701
Associate Principal Scientist
The Associate Principal Scientist position will support our Bacillus Calmette Guerin (BCG) franchise. This broad role includes driving method alignment and supporting consistent executional excellence across multiple testing laboratories, maintaining a robust assay monitoring effort, supporting method procedure life cycle management including automation and/or modernization as applicable, and many other cross functional interactions. This position is technical in nature and demonstrated expertise in vaccine analytics is required. The role also requires effective collaboration with external contract providers as well as colleagues in our research laboratories, supply chain, site and global Quality, as well as CMC-Regulatory. This role will be based in Durham, NC, and it's a site-based position. Responsibilities Include But Are Not Limited To:
Ensure execution of test methods is aligned and sustainable across multiple QC laboratories Provide Subject Method Expertise to QC analysts and supervisors, assess impact of proposed changes and deviations. Responsible for assay monitoring ensuring method performance data are presented, discussed and actions developed at analytical working group meetings as appropriate. Collaborate across the internal network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) to ensure uninterrupted supply of BCG Coordinate with analytical and process development groups to prepare for and coordinate analytical troubleshooting, validation and technology transfers between Company sites as well as and CMO/CROs Provide input into cross-functional teams and ensure alignment with analytical strategies and Quality Systems in support of analytical procedure life cycle management. Act as subject matter expert informing development and optimization of existing analytical methods to enable modernization of our testing strategies. Accountability for analytical method transfers and in-line assay method validations, including review of protocols and reports. Escalation of key assay challenges to management in a timely and concise manner. Partnership with critical reagent and reference standard groups to ensure unconstrained supply of reagents required for routine analytical testing. Perform technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methods. Coordinate analytical issue resolution via subject matter experts within the global large molecule network. Support RTQs, PAI readiness and audit observations Minimum Education Requirement And Experience:
Bachelor's Degree (BA/BS) with a concentration in sciences with six (6) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR Master's Degree (MA/MS) with a concentration in sciences with four (4) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR PhD with a concentration in sciences with two (2) years of experience working in the field of analytical testing, development, transfer, and/or validation. Required Experience And Skills:
Demonstrated experience with analytics for commercial vaccine and/or microbiological products. Effective communication and teamwork. Experience with large molecule GMP testing, including drug substance and drug product stability and release testing. Experience with analytical comparability. Experience leading a cross-functional team. Strong technical expertise in general large molecule analytical laboratory operations, equipment, and techniques. Preferred Experience And Skills:
Continuous improvement or Project Management training. Writing or review of technical documents, preferably including regulatory filings (IND, MAA, BLA, PAS, CBE) and inspections with multiple agencies (FDA, EMA, JNDA). Experience with large molecule analytical transfers. Experience with commercial product analytical method changes. Experience with assay monitoring and trending. The salary range for this role is $139,600.00 - $219,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at
https://jobs.merck.com/us/en/compensation-and-benefits .
The Associate Principal Scientist position will support our Bacillus Calmette Guerin (BCG) franchise. This broad role includes driving method alignment and supporting consistent executional excellence across multiple testing laboratories, maintaining a robust assay monitoring effort, supporting method procedure life cycle management including automation and/or modernization as applicable, and many other cross functional interactions. This position is technical in nature and demonstrated expertise in vaccine analytics is required. The role also requires effective collaboration with external contract providers as well as colleagues in our research laboratories, supply chain, site and global Quality, as well as CMC-Regulatory. This role will be based in Durham, NC, and it's a site-based position. Responsibilities Include But Are Not Limited To:
Ensure execution of test methods is aligned and sustainable across multiple QC laboratories Provide Subject Method Expertise to QC analysts and supervisors, assess impact of proposed changes and deviations. Responsible for assay monitoring ensuring method performance data are presented, discussed and actions developed at analytical working group meetings as appropriate. Collaborate across the internal network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) to ensure uninterrupted supply of BCG Coordinate with analytical and process development groups to prepare for and coordinate analytical troubleshooting, validation and technology transfers between Company sites as well as and CMO/CROs Provide input into cross-functional teams and ensure alignment with analytical strategies and Quality Systems in support of analytical procedure life cycle management. Act as subject matter expert informing development and optimization of existing analytical methods to enable modernization of our testing strategies. Accountability for analytical method transfers and in-line assay method validations, including review of protocols and reports. Escalation of key assay challenges to management in a timely and concise manner. Partnership with critical reagent and reference standard groups to ensure unconstrained supply of reagents required for routine analytical testing. Perform technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methods. Coordinate analytical issue resolution via subject matter experts within the global large molecule network. Support RTQs, PAI readiness and audit observations Minimum Education Requirement And Experience:
Bachelor's Degree (BA/BS) with a concentration in sciences with six (6) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR Master's Degree (MA/MS) with a concentration in sciences with four (4) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR PhD with a concentration in sciences with two (2) years of experience working in the field of analytical testing, development, transfer, and/or validation. Required Experience And Skills:
Demonstrated experience with analytics for commercial vaccine and/or microbiological products. Effective communication and teamwork. Experience with large molecule GMP testing, including drug substance and drug product stability and release testing. Experience with analytical comparability. Experience leading a cross-functional team. Strong technical expertise in general large molecule analytical laboratory operations, equipment, and techniques. Preferred Experience And Skills:
Continuous improvement or Project Management training. Writing or review of technical documents, preferably including regulatory filings (IND, MAA, BLA, PAS, CBE) and inspections with multiple agencies (FDA, EMA, JNDA). Experience with large molecule analytical transfers. Experience with commercial product analytical method changes. Experience with assay monitoring and trending. The salary range for this role is $139,600.00 - $219,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at
https://jobs.merck.com/us/en/compensation-and-benefits .