Executive Director Biologics Drug Substance Commercialization
Executive Director Biologics Drug Substance Commercialization
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$ 227300 - 357900
1 Vacancy
Job Description
Job Description
Our Engineers support internal and external manufacturing operations remain operational continuously improve and innovate. With our extensive range of facilities and environments our Engineers have opportunities across many diverse areas including Biological Chemical Automation Capital Projects Maintenance Safety Process Development Technical Services Utilities and Validation.
The Executive Director Biologics Drug Substance Commercialization (BDSC) will report directly to the Vice President of Biologics Science & Technology and will be accountable for delivery of late stage development and commercialization activities associated with drug substance of our pipeline biologic assets. The incumbent will partner closely with the scientific functions within our research and development division as well as the broader Our Manufacturing Division to deliver integrated controls strategies that are optimized across the dimensions of cost quality and the Biologics Drug Substance Commercialization organization will be responsible for delivering world class outcomes in the following areas:
Deliver integrated control strategy and process design elements including process characterization and second generation process development for drug substance processes across multiple expression systems
Deliver technology transfer and PPQ elements for drug substance processes in partnership with internal and external manufacturing sites
Author and review relevant elements of global regulatory submissions
Recruit and develop a world class workforce
Ensure core operations and laboratories are compliant with our companys Operating Procedures and phase appropriate GMP standards where applicable
Ensure a safe workplace for staff across multiple laboratory settings
Leadership within and across our companys technical functions
Develop and advance cutting edge technologies and business practices
Cochair the Development Council to enable decision making and guidance in order to advance our pipeline assets strategically and technically
Create strategic partnerships with external technical collaborators
Education Requirement:
Bachelors Degree in life sciences or equivalent with at least: 15 years of relevant experience a Masters degree (MS) with 12 years of relevant experience or PhD with 10 years relevant experience
Required Experience and Skills:
Must have expertise and understanding in the commercialization of large molecule drug substance processes
Direct experience with management of large multidisciplinary scientific organization
Excellent written and verbal communication skills. Ability to effectively communicate and influence at all levels of the organization
Preferred Experience and Skills:
Demonstrated track record of successfully commercializing multiple large molecule programs across a variety of platforms
Expert knowledge in global regulatory requirements for large molecule commercialization and BLA assembly
Expert knowledge in QbD
Excellent organization skills and be able to manage multiple projects simultaneously. Excellent interpersonal skills and ability to work
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:
Pay Transparency Nondiscrimination
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 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:
DomesticVISA Sponsorship:
NoTravel Requirements:
25Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
YesHazardous Material(s):
NAJob Posting End Date:
04/18/2025*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
