Director, MS&T Downstream Laboratory Lead

Gaithersburg, US   |   full time   |   Job ID: 10717 

Primary responsibilities:

• Provide scientific and strategic leadership for the Gaithersburg MSAT Downstream Laboratory
• Collaborate with various teams (Supply Chain, Process Development, AS&T, Analytical Development, Quality, Regulatory) to establish and run the upstream MSAT laboratory in support of global programs in close partnership with process development

• Provide direct hands-on management of the Gaithersburg MSAT Downstream Laboratory.
• Develop phase appropriate downstream scale down models for antibody programs
• Participate in knowledge and technology transfers for antibody and ADC programs to enable design and execution of downstream characterization, investigational and scale-down model studies to support tech transfers and on market support.

• Coach and develop MSAT team members on downstream antibody manufacturing processes, laboratory activities and studies.
• Foster a culture of scientific rigor, Innovation and continuous improvement.
• Play critical leadership role in designing, developing, characterizing, and qualifying downstream processes (includes chromatography, filtration, viral inactivation and filtration, UFDF concentration, formulation and and cryopreservation)
• Draft SOPs, reports, and presentations
• Maintain and troubleshoot instrumentation and equipment.
• Collaborate with both internal teams and external groups to advance late-stage antibody capabilities
• Support data analysis and present results within the team and to broader scientific groups
• Maintain a high standard of good documentation practice, experimentation and record keeping
• Work productively in a team environment and independently to deliver against timelines
• Lead projects, CAPAs and deviations/ investigations and/ or continuous improvement efforts
• Support technology transfer to GMP from contract manufacturers or the internal process development team, including process/facility gap assessments and drafting/reviewing GMP documents (batch records, tech transfer protocols, sampling plans)

• Collaborate closely with downstream tech transfer teams and the Process Validation team to ensure PPQ readiness; contribute to PPQ protocol authoring and review ensuring GMP compliance and scientific rigor

Requirements:

• MS degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, or related discipline with 12 plus years of pharmaceutical / biotechnology process development industry experience.  

• In-depth CMC knowledge in either early or late-stage antibody technology transfer projects with sound understanding of all stages of antibody drug development, GMP, and QbD approach; Experience with antibody or ADC on market technical support is considered a plus
• Proven success leading cross-functional CMC teams and stakeholder/client management
• Strong organizational, troubleshooting, and interpersonal skills along with excellent oral and written communication
• Proven ability to design and perform complex projects while shaping scientific strategy both at the platform and program level

• Proven ability to work independently, effectively plan and organize work activities and prioritize task completion to meet project deadlines

• Demonstrated strategic & enterprise thinking
• Experience as subject matter expert for antibody downstream processes

• Demonstrated collaboration with GMP Manufacturing, Quality Control, Quality Assurance, Engineering, Regulatory Affairs and Process Development within technology transfer projects and product commercialization

Preferred requirements: PhD

US based candidates expected Pay Range: $168,100 - $268,700/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

Your Benefits

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance

…and more! More details to be shared.
 

Located in the BioHealth Capital Region near Washington DC and ranked among the top biopharma hubs in the country, Gaithersburg, Maryland offers a unique and diverse cluster across industry, government, and academia for top talent and scientific innovation. As a pivotal player within the life sciences community, Gaithersburg is distinguished by its robust infrastructure and strategic location near the nation’s capital. The city’s strategic significance is amplified by its state-of-the-art manufacturing facilities that cater to the rigorous demands of the life sciences industry; Gaithersburg’s manufacturing sector is defined by advanced technologies and complies with the most stringent regulatory standards, ensuring the production of high-quality pharmaceuticals, biologics, and medical devices. In the coming years, Gaithersburg will continue to be a vital contributor to the future of medical science and technology.

Apply now - We look forward to your application!

Apply for our Gaithersburg, US location and simply send us your documents using our online form.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.