Executive Director, Biologics Drug Substance Commercialization (BDSC)
Executive Director, Biologics Drug Substance Commercialization (BDSC)
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$ 227300 - 357900
1 Vacancy
Job Description
Job Description
Are you ready to take a leading role in shaping the future of biologics Join our company a pioneer in researchintensive 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 worldclass results.
Your Core Responsibilities:
Lead the development of integrated control strategies and process design elements including process characterization and secondgeneration 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 worldclass workforce providing opportunities for growth and development.
Ensure compliance with our companys Operating Procedures and phaseappropriate 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 companys technical functions.
Develop and advance innovative technologies and business practices.
Cochair 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 multidisciplinary 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.
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 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:
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 anothers 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 officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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.
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 candidates relevant skills experience and education.
Expected US salary range:
$227300.00 $357900.00Available benefits include bonus eligibility long term incentive if applicable health care 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 preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
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 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.
Required Experience:
Director
Employment Type
Full-Time
