Associate Principal Scientist/Associate Director, Engineering- Biologics Drug Substance Commercialization jobs in United States
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Merck · 9 hours ago

Associate Principal Scientist/Associate Director, Engineering- Biologics Drug Substance Commercialization

Merck is at the forefront of innovation in the biopharmaceuticals purification industry, seeking an individual to lead their Biologics Drug Substance Commercialization team. The role involves leading cross-divisional technical teams, driving innovation in process validation, and mentoring junior staff to ensure excellence in execution.

BiotechnologyHealth CareMedicalPharmaceutical
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Comp. & Benefits
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H1B Sponsorednote

Responsibilities

Participate in and/or spearhead cross-divisional technical teams focused on late-stage clinical process development, characterization, and technology transfer of biopharmaceutical drug substance processes
Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization
Design experiments, analyze data, and mentor junior staff, ensuring excellence in execution
Provide technical leadership in interpreting trends from commercial process monitoring, driving further investigations and process improvements that elevate our standards
Actively interact with internal and external partners, representing your functional area on cross-functional teams to foster collaboration and innovation
Author regulatory and technical documentation, ensuring all processes align with our company’s expectations
Manage a small team of junior staff, guiding them in their professional development

Qualification

Biological EngineeringBiologicsChromatographyTechnology TransferData AnalysisProcess CharacterizationManufacturing Process ValidationLeadership ExperienceCommunicationMentorshipDetail-OrientedTeam Management

Required

A degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry with relevant experience
10 years with a bachelor's degree
8 years with a master's degree
4 years with a PhD
Proficient in the purification of biological molecules, including chromatography and filtration systems
Proven track record in tech transfer or scaling up processes for biologics manufacture
Exceptional oral and written communication abilities to articulate complex concepts in a multi-disciplinary team environment
Experience leading teams and fostering career development for junior staff

Preferred

In-depth knowledge of harvest, preparative chromatography, and filtration techniques
Experience in pilot or commercial scale manufacturing of biological molecules
Familiarity with late-stage process development, process characterization, process validation regulatory submissions, and working with external contract organizations
Proficiency in statistical methods for design of experiments (DOE) and data analysis, as well as statistical process control (SPC) and multivariate analysis (MVA)

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