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Job Description

Associate Principal Scientist, Biologics, Sterile Drug Product Commercialization

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 biologics and combination 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 biologics and combination products.

We are seeking an experienced Associate Principal Scientist to advance and commercialize biologics pipeline program. As a member of the biologics drug product team, the Associate 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:

• Leads and/or serves on cross functional biologics 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 (PreApproval Inspection) readiness, approval, launch and postlaunch 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 10 years of relevant experience; or

• Master's degree in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant experience; or

• Ph.D. in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 4 years of relevant experience

Required Experience and Skills:

• Experience with drug product process development, optimization, and/or process characterization of biologics

• Experience with at scale biologics drug product manufacturing and fill finish operations

• 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 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 late-stage commercialization of biologics programs

• 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 biologics and other sterile drug products

Required Skills:

Preferred Skills:

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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 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:

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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.

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The salary range for this role is

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.

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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

Relocation:

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Travel Requirements:

Flexible Work Arrangements:

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