Merck
From Merck's careers page
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The role reports to the US regional process development lead.
Associate Director, Process Development Large Molecules
The Global Animal Health Manufacturing (GAHM) Biotechnology Solutions (BTS) group is seeking a highly motivated individual to be part of process development group in the US. Process Development (BTS-PD) group is accountable for technology transfer of new large molecule products from R&D to commercial production. This team leads critical technical activities such as scale-up, process validation/qualification, and process optimization & robustness to ensure successful product launches to enable robust product supply.
Associate Director is accountable for developing robust processes for new products and transferring large molecule pipeline projects from R&D to operations in the US region. The role reports to the US regional process development lead. Associate Director will be responsible for managing a high-performing team to deliver robust processes for various projects in the pipeline and transfer to manufacturing facilities. This role also requires managing strategic priorities and technical projects as needed and requires collaboration across matrix organization for collective success, including R&D, operations, site-support, supply chain and regulatory in the US region.
Process Development – Accountable for development of robust processes and, right-first-time technology transfer of processes from R&D to operations for antigens and final products to meet file on time and launch on time targets. Collaborate with partner groups (R&D, operations, quality, regulatory) to ensure file/launch on time.
People Management – Accountable for building and sustaining a highly engaged technology transfer team through utilization of our Ways of Working. Drives culture of safety, compliance, technical excellence, and employee development. Directly manages and coaches the technology transfer team. Provides team members with aligned objectives, regular feedback on performance (including soliciting stakeholder feedback), development conversations and career progression opportunities. Proactively engages in talent management, retention, and succession planning.
Technical Excellence – Accountable for data-driven decision making across technology transfers. Drives continuous process improvements when required to enhance process and/or decrease cost-of-goods (COGs). Oversees appropriate risk identification and mitigation methodologies (e.g. FMEA) to drive decisions. Manages technical stage-gate reviews, where appropriate. When needed, accountable for driving execution of appropriate lab experiments to reduce risk, increase robustness, or reduce COGs.
Strategic Leadership – Accountable for managing strategic initiatives and overseeing execution by the technology transfer team. Additionally acts as a contributor to the Regional Technology Hoshin by aligning internal goals with the technology organization.
Bachelor of Science in Chemical Engineering, Biotechnology, Biochemistry, Protein Chemistry, Biology or related field.
Bachelor’s with at least (8) years of relevant post-graduate experience OR Master of Science degree and at least (6) years of relevant post-graduate experience OR doctoral degree with at least (4) years of relevant post-graduate experience
Minimum of (3) years of direct management experience
Minimum four (4) years of relevant experience in technology transfer, process development, technical operations, or manufacturing operations within a regulated biopharmaceutical environment
Demonstrate as an effective project leader who can maintain oversight, manage priorities, and deliver on-time results in a complex, fast-paced matrix organization
Strong working knowledge of EMA, FDA, and/or USDA regulations and guidelines
Demonstrated commitment to Diversity, Equity, & Inclusion
Demonstrated successes with Talent Management, process development/technology transfer and strategic initiatives
Demonstrated experience with USDA regulations
Demonstrated experience in commercial biomanufacturing (sterile/aseptic, bulk drug substance, filling, lyophilization, etc.) in a regulated environment
Strong working knowledge of key biopharmaceutical business processes, including Process Performance Qualification/Validation, risk assessments, CMC regulatory processes, and manufacturing change control
Demonstrated experience with statistical process control and/or design of experiments
Biopharmaceutical Industry, Coaching Employees, Decision Making, Life Sciences Industry, Life Sciences R&D, People Leadership, Process Development (PD), Technical Operations, Technology Transfer
Design of Experiments (DOE), Strategic Technology Initiatives, USDA Regulations
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Current Contingent Workers apply HERE
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
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. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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USA - Nebraska - Elkhorn
Where required by law, the compensation range for this role is provided below.
$142,400.00 - $224,100.00
This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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.
Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Regular
Domestic
No
10%
Not Applicable
1st - Day
Yes
N/A
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