Associate Director, Engineering, Biologics Pilot Plant

Job Description

Position Description:

Associate Director, Engineering, Biologics Pilot Plant

The Associate Director, Engineering is responsible for providing strategic and technical leadership of a team responsible for maintaining the infrastructure and GMP status of the Biologics Clinical Manufacturing and Technology pilot plant facility. This includes interfacing with process operations groups as well as site support groups to ensure facility readiness for the GMP manufacture of biopharmaceutical/vaccine clinical products. Additional team responsibilities include managing the inventory of cell banks and finished drug substance.

ACCOUNTABILITY

The incumbent will be accountable for the development of the staff within his/her team. She/he will help develop a high performing team, which includes; yearly priority setting, periodic performance reviews, employee development and recommendations within the framework of Company policy. They will also be responsible for resource planning, risk assessment strategies and budget management, as necessary.

DUTIES

Compliance -

• Oversee operating procedures, facility, inventory, and equipment compliance, and support internal and external inspections. 

• Management of infrastructure compliance functions and participation on key compliance teams and initiatives.

Continuous Improvement -

• Ability to set strategy for continuous quality improvement within the infrastructure team.

People Management –

• Leading teams and project initiatives; proven ability to work collaboratively in a complex, matrix environment; foster team productivity and cohesiveness; and the ability to drive innovation within the team and organization.

The successful candidate will be responsible for maintaining a strong internal and external network, across the industrial and academic community, promoting collaboration and fostering effective working relationships.

Position Qualifications:

Education Minimum Requirement:

• BS or MS with minimum 8 years of strong, relevant experience

Required Experience and Skills:

• Overall, a minimum of 4 years relevant experience in biopharmaceuticals.

• Demonstrated ability to meet firm deadlines in support of product discovery, development and commercial filings for biopharmaceutical or vaccine products.

• Experience working in a regulated environment in support of Good Manufacturing Practices (GMP) activities.

• The individual should be highly motivated with the ability to work in a fast-paced setting.

Preferred Experience and Skills:

• Expertise in regulatory compliance expectations in facilities, equipment, and inventory management across all phases of product development to commercialization.

• Expertise in biological and/or vaccine manufacturing would be ideal.

• Demonstrated leadership skills, e.g., building high performing teams, ability to motivate, influence, develop/coach others, lead by example through scientific/technical expertise.

• Highly motivated and flexible with ability to work in a fast-paced environment.

• Ability to provide novel creative solutions to challenging problems.

• Encourages innovative thinking/risk taking and eliminates obstacles/barriers to implement change.

• Ability to present clear and compelling quality and business cases.

Current Employees apply HERE

Current Contingent Workers apply HERE

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 click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  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 diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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

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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:

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Job Posting End Date:

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