Assoc. Dir., Engineering

Merck & Co.

Elkhorn Precinct (NE)

On-site

USD 142,000 - 224,000

Full time

2 days ago

Be an early applicant

Application generator

Stand out for this role — generate a tailored resume and cover letter in about a minute.

Get past ATS filters

Benefits offered by this job

Annual bonus

Long-term incentive

Job summary

Merck & Co. is seeking an Associate Director, Process Development Large Molecules in the US region to lead technology transfer of biopharmaceutical processes from R&D to manufacturing, ensuring file readiness and launch on time.

You will manage a high-performing team, drive continuous improvement, and collaborate across R&D, operations, quality, regulatory, and supply chain to deliver robust processes for a diverse pipeline.

Qualifications

Bachelor's with at least 8 years of relevant post-graduate experience OR MS with 6+ years OR PhD with 4+ years of relevant post-graduate experience
Minimum of 3 years of direct management experience
Minimum four (4) years of experience in technology transfer, process development, technical operations, or manufacturing operations in a regulated biopharmaceutical environment
Demonstrate effective project leadership and ability to work in a complex matrix organization
Strong knowledge of EMA, FDA, and/or USDA regulations and guidelines
Commitment to Diversity, Equity, & Inclusion

Responsibilities

Develop robust processes and right-first-time technology transfer from R&D to operations for antigens and final products
Build and sustain a high-performing technology transfer team with a safety and technical excellence culture
Drive data-driven decisions and manage risk to reduce costs and improve robustness
Lead strategic initiatives and coordinate with R&D, operations, quality, regulatory, and supply chain across the US region

Skills

Biopharmaceutical Industry

Coaching Employees

Decision Making

Life Sciences Industry

Life Sciences R&D

People Leadership

Process Development

Technical Operations

Technology Transfer

Education

Bachelor of Science in Chemical Engineering

Job description

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
D emonstrated 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:

Biopharmaceutical Industry, Coaching Employees, Decision Making, Life Sciences Industry, Life Sciences R&D, People Leadership, Process Development (PD), Technical Operations, Technology Transfer

Preferred Skills:

Design of Experiments (DOE), Strategic Technology Initiatives, USDA Regulations

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.

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.

Salary range for this role is

$142,400.00 - $224,100.00

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.

Benefits package

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.

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

Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

Travel Requirements

10%

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License