Job Description

Are you ready to take a leading role in shaping the future of biologics? Join our company, a pioneer in research-intensive biopharmaceuticals, and be at the forefront of delivering innovative health solutions that transform the prevention and treatment of diseases. As the Executive Director of Biologics Drug Substance Commercialization, you will be crucial in driving the success of our biologic assets within the pipeline. Collaborate directly with our research and development division and manufacturing teams to enhance strategies across cost, quality, and speed dimensions, achieving world-class results.

Your Core Responsibilities

• Lead the development of integrated control strategies and process design elements, including process characterization and second-generation process development for drug substance processes across diverse expression systems.
• Facilitate technology transfer and PPQ elements for drug substance processes in collaboration with internal and external manufacturing sites.
• Author and review key elements of global regulatory submissions.
• Recruit and nurture a world-class workforce, providing opportunities for growth and development.
• Ensure compliance with our company's Operating Procedures and phase-appropriate GMP standards in core operations and laboratories.
• Maintain a safe and supportive workplace for staff across multiple laboratory settings.
• Provide visionary leadership within and across our company's technical functions.
• Develop and advance innovative technologies and business practices.
• Co-chair the Development Council, enabling strategic and technical guidance to advance our pipeline assets.
• Cultivate strategic partnerships with external technical collaborators.

Education Minimum Requirements

B.S. in relevant Engineering or Science fields.

Who You Are

You are ready if you have the following requirements:

• At least 15 years of experience in biopharmaceutical manufacturing and/or development, emphasizing science and technical roles.
• Expertise and understanding in the commercialization of large molecule drug substance processes.
• Proven experience in managing large, multi-disciplinary scientific organizations.
• Excellent written and verbal communication skills with the ability to effectively communicate and influence at all levels of the organization.

Preferred Experience And Skills

• Demonstrated success in commercializing multiple large molecule programs across various platforms.
• Expert knowledge in global regulatory requirements for large molecule commercialization and BLA assembly.
• Proficiency in QbD principles.
• Strong organizational skills with the ability to manage multiple projects simultaneously.
• Excellent interpersonal skills and ability to work collaboratively.

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.

Requirements

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”.

Salary and Benefits

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US Salary Range

$227,300.00 - $357,900.00

Available benefits include bonus eligibility, long-term incentive if applicable, healthcare and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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:

VISA Sponsorship

Travel Requirements:

Flexible Work Arrangements

Hybrid

Shift

Valid Driving License:

Hazardous Material(s)

Job Posting End Date:

05/27/2025

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.

Requisition ID:

R348703