Merck · 8 hours ago
Associate Principal Scientist/Associate Director, Engineering- Biologics Drug Substance Commercialization
USA - New Jersey - Rahway
Full-time
Hybrid
Lead/Staff, Director/Executive
$142K/yr - $224K/yr
8+ years expMerck is at the forefront of innovation in the biopharmaceuticals sector, specifically within the Biologics Drug Substance Commercialization team. The role involves leading cross-divisional technical teams, driving innovation in process development, and mentoring junior staff to enhance the commercialization of biologics.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Lead and Collaborate: 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. Your insights will be crucial for establishing an integrated control strategy suitable for commercialization and licensure for the products in our expanding late-stage biologics portfolio
Drive Innovation: Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization. You’ll design experiments, analyze data, and mentor junior staff, ensuring excellence in execution
Enhance Process Understanding: Provide technical leadership in interpreting trends from commercial process monitoring, driving further investigations and process improvements that elevate our standards
Engage Across Functions: Actively interact with internal and external partners, representing your functional area on cross-functional teams to foster collaboration and innovation
Document Excellence: Author regulatory and technical documentation, ensuring all processes align with our company’s expectations
Mentor Future Leaders: If you have a knack for leadership, you will also manage a small team of junior staff, guiding them in their professional development
Qualification
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
Technical Expertise: Proficient in the purification of biological molecules, including chromatography and filtration systems
Technology Transfer Experience: Proven track record in tech transfer or scaling up processes for biologics manufacture
Communication Skills: Exceptional oral and written communication abilities to articulate complex concepts in a multi-disciplinary team environment
Leadership Experience: Experience leading teams and fostering career development for junior staff
Biological Engineering
Biologics
Biomedical Engineering
Bioprocessing
Chemical Engineering
Chromatography
Communication
Data Analysis
Decision Making
Detail-Oriented
Downstream Manufacturing
Maintenance Supervision
Manufacturing Process Validation
Mentorship
Process Characterization
Protein Purifications
Team Management
Technical Leadership
Technology Transfer
Written Communication
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 and other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
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