Associate Principal Scientist, Sterile Product Development jobs in United States
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Merck · 14 hours ago

Associate Principal Scientist, Sterile Product Development

Merck is a leading global healthcare company, and they are seeking an Associate Principal Scientist focused on developing parenteral drug products. The role involves leading innovative approaches for biologics sterile product development and requires collaboration in a fast-paced, multidisciplinary team environment.

BiotechnologyHealth CareMedicalPharmaceutical
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Comp. & Benefits
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H1B Sponsorednote

Responsibilities

Lead/ contribute towards the new, innovative approaches for biologics sterile product development through the generation of experimental designs, execution of experimental plans and data analysis
Support both early and late-stage development candidates, including screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for processing and administration, and supporting regulatory filings
Build deep fundamental knowledge around the drug product to ensure completion of key milestones and laboratory / regulatory documentation
Active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across functions to drive defined milestones will be required
Responsible for leading and championing organizational strategic and innovation objectives aligned with organizational goals
Be willing to take initiative, motivated to excel, have a strong technical background, have excellent communication and interpersonal skills, ability to multi-task, mentor scientists, and a strong desire to learn and contribute
Leads project activities at external manufacturing sites including tech transfers
Enhance our Company's professional image and competitive advantage through patents, presentations, publications and professional activities and advance areas such as science and technology development, technical and business strategic improvements, business process innovations
Maintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with others

Qualification

Biologics process developmentFormulation developmentDrug development processTechnical leadershipSurface scienceColloid scienceParticle engineeringRegulatory filingsCommunication skillsMentoring skillsTeam collaboration

Required

Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 4 years relevant industry experience
B.S. or M.S. degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 8 years relevant industrial experience
Experienced in biologics process development and characterization particularly for late stage programs
Capable of leading formulation development activities in matrix team environments to define a robust formulation and manufacturing process
Recognized as a technical expert and scientific contributor with proven ability to identify and develop innovative ideas
Has broad knowledge of formulation science and in depth-knowledge in multiple areas, including core understanding of the drug development process
Track record of working effectively with team-members of diverse skill sets and backgrounds
Strong verbal and written communication skills
The candidate should have a strong track record in product development/ regulatory filing/ drug delivery/ complex formulation and process development/ characterization reflected through industry experience and external publications/ patent

Preferred

Deep understanding of one or more of the following: surface science, colloid science, particle engineering and/or high concentration formulations
Prior experience leading development projects at an enterprise level
Capable of mentoring individuals in a peer-to-peer fashion and as a technical mentor
Recognized as a subject matter expert in at least one drug delivery and/or manufacturing technology
Demonstrated ability to identify, fundamentally characterize and address manufacturing challenges through the development and optimization of novel production technologies
Desire to build new capabilities through the evaluation of new technologies and hands-on optimization of existing technologies
Prior experience with process scale up, modeling, regulatory filings and/or driving key capability evaluation/ build would be highly preferred

Benefits

Medical
Dental
Vision healthcare
Other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days

Company

Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.

Funding

Current Stage
Public Company
Total Funding
$5.59M
Key Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO

Leadership Team

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Betty Larson
Executive Vice President and Chief Human Resources Officer
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Dean Li
Executive Vice President and President, Merck Research Laboratories
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Company data provided by crunchbase