Merck
Director, Raw Materials & Medical Device Analytical R&D
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Director, Raw Materials & Medical Device Analytical R&D
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Merck Job Overview
Location: Rahway, NJ. The Primary objective of the Small Molecule Analytical Research & Development (SMAR&D) GxP Operations team is to carry out analytical GMP activities partnering across the network to enable clinical supplies. Primary Responsibilities
Lead a team of specialists and scientists supporting raw material release and medical device & combination product testing. Ensure on-time release testing of raw materials to enable clinical manufacture, right first time. Oversee contract laboratory investigations and deviations. Review and approve GMP data, release specifications, analytical reports, Certificates of Analysis, and SOPs. Serve as the raw material and MDCP SME during internal and external compliance audits. Drive process improvements and operational excellence. Staff development and talent recruiting. Partner with leadership to advance departmental strategic and cultural initiatives. Education & Minimum Requirements
BS or MS in chemistry or related science with 10 years of industrial experience with pharmaceutical drug substance and/or product development. Ph.D. in chemistry or related science with 7 years of industrial experience with pharmaceutical drug substance and/or product development. Required Experience & Skills
Excellent scientific communication skills, demonstrated creativity, effective interpersonal and collaborative skills. Demonstrated ability to lead teams to deliver high-quality results against firm deadlines. Proven talent development skillsets. Ability to partner in a team environment with cross-functional interactions to drive results. Preferred Experience & Skills
Prior experience managing a GMP lab that supports raw material, excipient, and/or package component release testing. Prior experience with medical device components and combination products is a plus. Salary
$169,700.00 - $267,200.00 Benefits Summary
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision, healthcare and other insurance benefits, retirement benefits, 401(k), paid holidays, vacation, and compassionate and sick days. Equal Opportunity Employer
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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Join to apply for the
Director, Raw Materials & Medical Device Analytical R&D
role at
Merck Job Overview
Location: Rahway, NJ. The Primary objective of the Small Molecule Analytical Research & Development (SMAR&D) GxP Operations team is to carry out analytical GMP activities partnering across the network to enable clinical supplies. Primary Responsibilities
Lead a team of specialists and scientists supporting raw material release and medical device & combination product testing. Ensure on-time release testing of raw materials to enable clinical manufacture, right first time. Oversee contract laboratory investigations and deviations. Review and approve GMP data, release specifications, analytical reports, Certificates of Analysis, and SOPs. Serve as the raw material and MDCP SME during internal and external compliance audits. Drive process improvements and operational excellence. Staff development and talent recruiting. Partner with leadership to advance departmental strategic and cultural initiatives. Education & Minimum Requirements
BS or MS in chemistry or related science with 10 years of industrial experience with pharmaceutical drug substance and/or product development. Ph.D. in chemistry or related science with 7 years of industrial experience with pharmaceutical drug substance and/or product development. Required Experience & Skills
Excellent scientific communication skills, demonstrated creativity, effective interpersonal and collaborative skills. Demonstrated ability to lead teams to deliver high-quality results against firm deadlines. Proven talent development skillsets. Ability to partner in a team environment with cross-functional interactions to drive results. Preferred Experience & Skills
Prior experience managing a GMP lab that supports raw material, excipient, and/or package component release testing. Prior experience with medical device components and combination products is a plus. Salary
$169,700.00 - $267,200.00 Benefits Summary
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision, healthcare and other insurance benefits, retirement benefits, 401(k), paid holidays, vacation, and compassionate and sick days. Equal Opportunity Employer
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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