Job Description
As part of Our Company's Manufacturing Division, the Sterile Drug Product Commercialization group provides the technical process leadership and laboratory capabilities for late stage and commercial drug product processes for vaccines, biologics, and sterile pharmaceutical products.
It is the division's leader in sterile product and process development, responsible for late-stage commercialization activities including process scale up, technology transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The group is responsible for establishing the science, engineering and knowledge required for today's innovative and accelerated commercialization of novel vaccines, biologics, and pharmaceutical products and combination products.
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We are seeking an experienced Principal Scientist to advance and commercialize an antibody-drug conjugate (ADC) pipeline program. As a member of the ADC drug product team, the Principal Scientist will have a key focus on driving excellence in process characterization, scale up, transfer and process validation activities.
Accountabilities and Responsibilities for this position include but are not limited to the following:
- Execute and provides oversight to ADC product and process design, development, characterization, technology transfer, and robust commercial validation
- Leads and/or serves on cross functional ADC drug product (DP) working groups and manages DP activities through filing and Process Performance Qualification (PPQ), including registration stability study execution, process characterization plan and execution, tech transfer control strategy, process development, PPQ readiness, PAI (Pre-Approval Inspection) readiness, approval, launch and post-launch support.
- Ensures commercialization programs meet requirements related to science, quality, reliability, schedule, and cost.
- Drives strategic initiatives (technical and/or business process related) in the department and with partner groups, that enable more efficient and rapid commercialization of innovative products
- Provides mentorship, technical oversight and strategic guidance to employees. Uses advanced experience gained on scientific/technical issues to guide others to address non routine and/or difficult issues.
- Develops a process and product development plan. Influences decisions related to primary packaging and combination product design.
- Responsible for the design and execution of DP development and commercialization studies, new product introduction and process validation at commercial sites.
- Ensures fit-for-purpose scale-down models are developed and employed. Establishes and validates platform engineering and scientific models for sterile product and process commercialization.
- Innovates and drives best practices for commercial site tech transfer, facility fit and development of the DP control strategy. Includes the classification of process parameters, performance parameters, operating ranges, in-process controls. Drives and influences process demonstration and qualification (PPQ) and shelf-life strategies.
- Influences CMC regulatory strategy and is accountable for DP CMC sections of filing. Reviews regulatory strategy and filing readiness and supports preparations for agency meetings. Authors and reviews regulatory submissions.
- Drives continuous and phase appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination product presentations.
- Establishes and fosters a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion.
Travel:
This position may require travel up to 25%; Must be able to travel for this position.
Position Qualifications:
Education Minimum Requirements
- B.S. in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 12 years of relevant experience; or
- Master's degree in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience; or
- Ph.D. in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant experience
Required Experience and Skills:
- Experience with drug product process development, optimization, and/or process characterization of ADCs
- Experience with at scale ADC drug product manufacturing and fill finish operations
- Experience with late-stage commercialization of ADC programs
- Technical expertise in sterile drug product fill finish related manufacturing processes for large molecules, including laboratory and/or fundamental models for key unit operations.
- Experience with technology transfer and scale-up of processes to pilot and/or manufacturing scales.
- Excellent oral and written communication skills. Ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc, in a multi-disciplinary team environment
Preferred Experience and Skills
- Experience in ADC and biologics drug product fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial
- Operations experience in the manufacturing of potent and sterile drug products, at pilot and/or commercial scale.
- Experience with commercialization of ADC programs through PPQ and launch
- Working knowledge in analytical methods and product attributes for ADCs
- Working knowledge of regulatory requirements for commercialization and registration of sterile drug products, including application of Quality by Design principles
- Working knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations.
- Working knowledge of statistical methods for DOE design and data analysis, statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for manufacturing processes
- Experience in Data Analytics, Computer Modeling, and Digital Applications (e.g. 3-D printing).
- Working understanding of analytical methods to characterize ADCs, biologics and other sterile drug products
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:
EEOC Know Your Rights
EEOC GINA Supplement
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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 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".
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:
$164,800.00 - $259,400.00
Available 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 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:
Domestic
VISA Sponsorship:
Yes
Travel Requirements:
25%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
12/11/2024
*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:R323218