Process Development - Associate Principal Scientist - Downstream
The Downstream Process Development Associate Principal Scientist functions in a supervisory role in the Downstream Process Development Group, actively engaged and engaging others in process development within a team based PD laboratory. The individual will independently lead customer projects and is expected to complete technical assignments through the self-sufficient design, execution and interpretation of complex experiments. The individual will be expected to significantly contribute to the technical growth and mentorship of the Downstream Process Development group, suggest new areas for development, present his or her own original ideas and research findings, and demonstrate a solid theoretical understanding within their own scientific discipline.
- Serves as a Technical Lead on multiple client projects, leading the experimental design, execution and communication of all the aspects for which they are responsible.
- Directs and leads the work of scientists and teams across multiple projects.
- Independently makes decisions affecting downstream transfer and development projects
- Serves as a Subject Matter Expert in several downstream technical categories
- Leads both Process Transfer and Process Development projects, delegating work to junior scientists, as appropriate.
- Delivers technical presentations in client-facing meetings, as well as presents data on behalf of FDBT during conferences, webinars, etc.
- Independently applies extensive scientific and/or cross-functional knowledge to design and direct plans for development and transfer activities
- Represents Downstream Process Development group as a technical SME during customer meetings
- Supervises junior and senior technical staff, including setting objectives and development plans, performance management, career development, training, mentoring, guiding, etc. Matrix management structure.
- Provides technical/scientific leadership within the department, and takes a lead in the improving the technical capabilities of Process Development Group.
- Provides input on the acquisition of capital equipment and assist in personnel hiring.
- Initiates new experimental approaches and related work processes and procedures that align with company and regulatory requirements.
- Perform all other duties as assigned
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.
Required Technical Knowledge and Experience
Individual will have extensive knowledge/expertise relevant to downstream processing of products expressed in mammalian, bacterial, insect and yeast cells. Knowledge/experience should focus on the following:
- Considerable experience with individual and/or group management, as well as originating and implementing individual or team improvement strategies
- Extensive theoretical and practical experience with chromatography based processing methods and tangential flow filtration techniques, including design and execution.
- Substantial experience with developing viral and/or protein purification strategies
- Expert understanding of protein and viral biochemistry (aggregation, degradation, protein folding, etc.).
- Thorough knowledge of protein and viral analytical techniques (HPLC, ELISA, PCR, SDS-PAGE, etc.)
- Proven experience with complex problem solving and prevention analysis, risk mitigation, affecting both PD and GMP activities
- Thorough understanding of cGMP regulations and procedures, as well as pilot scale manufacturing equipment with a focus on technical transfer into cGMP operations.
- Experience with formulation development strategies.
- Demonstrated experience with Drug Substance process characterization and risk mitigation
- Advanced understanding of Drug Product quality target product profiles and critical quality attributes and criteria
- Proven experience with data interpretation and presentation, statistical analysis and trending, and critical data management and recording in support of regulatory requirements.
- Extensive experience with a variety of downstream processing equipment and techniques.
Required Skills & Abilities:
- Excellent organizational, stress-management, people management, and communication skills
- Ability to direct and work closely with other members of a project group and receive and provide constructive feedback
- Ability to work and lead independently and reliably across multiple projects
- Builds credibility with the process development group by acting as a routine source for technical consultation
- Consistently finds opportunities to improve group functions and tasks, as well as continuously develops own technical skills and knowledge
- Strong problem solving skills and the possession of a solid understanding of the research literature associated with own scientific discipline; stay informed of current trends via journals, patents and personal networks of internal and external experts.
- Comprehensive knowledge of Microsoft Excel, Word, and PowerPoint, as and experience with Microsoft Visio.
- The ability to act as a lead in team oriented environment is essential, as this person will work closely with cross functional groups and participate on multidisciplinary project teams.
- Ability to mentor, train, and motivate a team of scientists, including providing ongoing coaching and feedback and providing input to department head regarding performance reviews and ensuring that the goals of the group are met.
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 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.
- Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
- Ability to lift 50 pounds on occasion and 25 pounds regularly.
- Ability to wear PPE.
- Attendance is mandatory.
Minimum Qualifications (in addition to required skills & abilities):
- PhD in a science related field and 4 years relevant experience; OR
- Master's Degree in a science related and 8 years relevant experience; OR
- Bachelor's Degree in a science related and 10 years relevant experience.
- At least 2 years' experience in a lead or supervisory role.
- Experience in pharmaceutical or biotechnology industry with cGMP experience.
- Hands-on downstream processing experience related to viral vector production.
- Degree in Biology, Microbiology, Chemistry, Biochemistry or a related field.
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.
If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3528.