Job Description

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.

Job Responsibilities:

• 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.

Required Education:

• Bachelor of Science in Chemical Engineering, Biotechnology, Biochemistry, Protein Chemistry, Biology or related field.

Required Qualifications:

• 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

Preferred Qualifications:

• 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

Required Skills:

Preferred Skills:

Current Employees apply

Current Contingent Workers apply

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process.

The salary range for this role is

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 .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.