- Manages and supervises the AMT group.
- Maintains up-to-date knowledge of regulatory guidelines and industry best practices.
- Participates in assessing analytical methods transferring in to FDBT Quality Control from client laboratories or partner FDB sites.
- Works closely with Program Management and PD leadership to coordinate project timelines, milestones, and priorities.
- Implements ongoing quality improvement processes and develops metrics for performance improvement of the team.
- Provides technical leadership in the design, execution, and management of qualification/validation/verification/technical transfer of a broad range of analytical methods for release and in-process cGMP testing of therapeutic proteins and gene therapy products.
- Oversees current and future instrumentation needs for the group.
- Demonstrates communication and interpersonal skills, including confident presentation of data, positive and lasting collaboration with colleagues across departments and FDB sites, forging positive relationships with external clients, the ability and confidence to challenge others when necessary and strong problem solving skills.
- Performs all other duties as assigned.
- Extensive hands on experience in several of the following technical fields: HPLC/UPLC, electrophoresis, spectroscopy, plate-based assays, PCR (including quantitative and droplet digital), viral titer assays.
- Extensive understanding of analytical instrumentation and methodologies.
- Leadership experience in an Analytical Development and/or Quality Control laboratory and experience working in a regulated cGMP environment.
- Understanding of data analysis tools and relevant statistical methods.
Required Skills & Abilities:
- Develops efficient ways of working for the group and streamlines the transfer of methods from Analytical Development to Quality Control.
- Strong oral and written communication skills.
- Ability to set personal performance goals and provide input to departmental objectives.
- Experience in applied research and development of virally-based therapeutics through early clinical development.
- Ability to support IND-related activities for recombinant vaccines and biotherapeutics.
- Experience with traditional and state of the art analytical instrumentation methods such as analytical chromatography.
- Development of technical solutions to complex problems which require the regular use of ingenuity and creativity.
- A strong attention to detail with a focus on product quality requirements.
- Proven experience in method development, qualification and transfer, along with comfort in a fast-paced work environment.
- Strong interpersonal and leadership skills.
- Strong computer skills (Microsoft Office products including Excel, Word, Outlook and PowerPoint).
Carries out supervisory responsibilities in accordance with company policies and applicable laws including interviewing, hiring, planning, assigning, directing work, training and development, disciplinary actions, performance reviews, addressing complaints and resolving problems.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged sitting/standing, along with some bending, stooping, and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
- Attendance is mandatory.
- Ability to sit for long periods of time to work on completion.
- May be required to life up to 25 pounds.
- Ph.D. preferably in Chemistry, Biology, Life Sciences or related field, with four (4) years of relevant experience; OR
- Master’s Degree preferably in Chemistry, Biology, Life Sciences or related field, with eight (8) years of relevant experience; OR
- Bachelor’s Degree preferably in Chemistry, Biology, Life Sciences or related field, with ten (10) years of relevant experience; AND
- Two (2) years of management/supervisory experience.
- Experience in pharmaceutical or biotechnology industry.
- Experience working in a contract manufacturing or testing organization is preferred.