Job Description

Job Description:

Seeking a candidate for a leadership position in our Research & Development Division Biologics Pilot Plant (BPP) Process Operations Team. We are recruiting a highly motivated and experienced person to lead teams of process engineers in Bioprocess Clinical Manufacturing and Technology. This role will focus on managing on the floor manufacturing of large molecule clinical drug substance campaigns, inclusive of vaccines and biologics. The ideal candidate will drive operational excellence, ensuring right-first time (RFT) batch execution on the manufacturing floor, while providing technical oversight for operators. The candidate will need to have a deep technical understanding in either upstream and downstream unit operations across a wide variety of vaccine and biologics processes as well as the ability to translate technical understanding into hands-on operational aptitude on the manufacturing floor. While a deep understanding in upstream or downstream is sufficient, the candidate should have a general understanding of end-to-end bioprocessing. The candidate will also need to collaborate across the program teams with the ability to influence functional leadership. This position is based on-site, in a fast-paced and dynamic setting, requiring adaptability and quick thinking.

In this position, you will exemplify our Company's leadership qualities by demonstrating integrity in all interactions, fostering a culture of innovation by encouraging creative solutions within your team, and embracing collaboration across functions to achieve common goals. You will hold yourself and your team accountable for delivering results, while also considering the long-term impacts of your decisions on our community and the environment. Additionally, you will champion diversity and inclusion by building a well-rounded team of subject matter experts, ensuring multiple perspectives contribute to our manufacturing processes.

Key Responsibilities:

• Manage and mentor a team of process engineers specializing in bioprocess manufacturing for large molecules (vaccines and biologics).

• Drive operational excellence for right-first-time (RFT) batch execution on the manufacturing floor.

• Provide technical oversight and guidance to operators in bioprocess manufacturing environments.

• Identify and build subject matter experts (SMEs) within the team to support a well-qualified and well-rounded manufacturing team.

• Collaborate with cross-functional teams to ensure agile pipeline deliverables are met

• Work on efficiency initiatives that support increasing operational excellence

Education Minimum Requirement:

• BS or MS degree in Engineering or Biological Sciences with a minimum of 10 years of relevant experience within the Pharmaceutical or Biopharmaceutical industry. PhD with a minimum of 7 years of relevant experience within the Pharmaceutical or Biopharmaceutical industry.

Required Experience and Skills:

• A highly motivated individual with the ability to work in a fast-paced and dynamic environment

• Demonstrated ability to mentor team members and influence cross-functional groups effectively

• Strong technical knowledge of fermentation and cell culture processes, including aseptic techniques, live virus handling, BSL2 practices, cleanroom protocols, and bioprocessing equipment

• Strong technical knowledge in purification processes such as chromatography, tangential flow filtration (TFF), and dead-end filtration

• Knowledge of the considerations required for transitioning from development to GMP (Good Manufacturing Practice) environments and influencing necessary adaptations

• Strong understanding of cGMP (current Good Manufacturing Practices), quality systems, and safety protocols within operations

• Proven leadership and project management skills to drive initiatives and team performance

• Hands on bioprocess experience either through labs or operations

• Previous experience in leading technical projects in either process development or GMP environments

Preferred Experience and Skills:

• Excellent organizational and problem-solving abilities

• Capability to work both independently and collaboratively, delivering strong results

• Exceptional conflict management and negotiation skills

• Ability to create and define a compelling vision, drive change, and influence decision-making within the organization

• Strong communication skills paired with personnel development aptitude

• Prior management experience is preferred

• Experience with SAP inventory management system and/or SAP QN

• Demonstration of Decision Making, Execution Excellence, Innovation, and Change Catalyst Leadership Skills

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.

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:

EEOC Know Your Rights

EEOC GINA Supplement​

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.

Learn more about your rights, including under California, Colorado and other US State Acts

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

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

04/25/2025

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