Process Development - Associate Principal Scientist-Analytical Method Transfer

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The Associate Principal Scientist – Analytical Method Transfer (AMT) focuses on the qualification and validation of Analytical Methods used at FUJIFILM Diosynth Biotechnologies (FDB). The AMT group is a protocol-driven group that primarily perform Tech Transfer, Qualification, and Validation of test methods coming out of the FDB analytical groups and transition them into our Quality Control group. The Associate Principal Scientist position will predominately focus on managing a group in AMT to create analytical method protocols and summary reports, executing protocols, reviewing data, ensuring a seamless transition to the QC group in a manner that sets them up for “right first time” and prolonged execution success, troubleshooting issues/spearheading investigations and working closely with the QA group and client. The individual will typically lead customer projects and as expected to complete technical assignments through the self-sufficient design, execution, and interpretation of complex experiments.

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Essential Functions:

• Manage a group(s)
  • to design and execute method transfers/qualifications/validations based on regulatory guidelines and industry best practices.
  • that perform assays to evaluate the accuracy, precision, specificity, linearity, robustness, and detection/quantitation limits of analytical methods.
• Act as a technical lead for client programs and provide updates and professional recommendations to external customers.
• Maintain a thorough understanding of project timelines and milestones and openly communicate scheduling challenges to internal and external stakeholders.
• Independently applies scientific and/or cross-functional knowledge to achieve project goals.
• Identifies, resolves technical project issues; ensures technical quality of work for project execution.
• Implements strategic departmental research and development goals or ideas.
• Responsible for some administrative and supervisory duties for the group.
• Plans client projects in terms of timing and resources.
• Accountable for accomplishing project goals and objectives; anticipates and prioritizes workflow to achieve desired outcomes.
• Monitors project plans and resources to ensure alignment with overall research goals and objectives.
• Provide technical leadership for higher level analyses involving analytical or process experimental design.
• Design, execution, and interpretation of complex laboratory experiments with broad priorities set by department head.
• Defining and implementing strategies, initiatives, and actions to improve processes and procedures to ensure compliance with internal and industry standards.
• May manage multiple large programs.
• Partner across company functions and collaborate effectively with respect to identifying and addressing problems and opportunities that affect or require input from multiple units within the company.
• All other duties as may be assigned.

Required Skills, Knowledge, and Abilities:

• As appropriate, write, review and approve SOPs/STM's/procedures/instructions, analytical plans, protocols/summary reports, departmental and inter-departmental reports for internal and external distribution.
• Ability to complete technical assignments by designing, executing, and interpreting complex experiments.
• Initiate new experimental approaches and related work processes and procedures that align with company and regulatory requirements.
• As appropriate, advanced application of statistical concepts for process design.
• Application of scientific knowledge to the design, conduct, and implementation of studies and projects.
• Creates plans to resolve project related issues.
• Ability to benchmark available technologies relative to other companies or industries.
• Contribute strong technical advice to team problem solving.
• Consistently prepares and presents complex scientific information to internal and external groups.
• Serves as an organizational spokesperson on technical issues for a specific area of expertise.
• May support Marketing & Sales activities such as proposal/scope of work review, present on behalf of department at client visits and provide laboratory tours.
• Operates across disciplines to influence scientific decisions.
• Prepares complex proposals and presentations for senior management, including issue identification and resolution.
• Develop stature in field of expertise by participation in scientific societies and meetings, review of current scientific literature and timely publications and/or patents.
• Direct communication with clients to communicate technical items and to resolve issues.
• May have communication with regulatory agencies, industry experts and consultants.

Preferred Skills & Abilities:

• 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.
• Experience with CFR 21-part 11 compliant software packages (such as Empower, SoftMax Pro).
• Experience working with a team of scientists in a direct or matrix environment.
• Experience working in or interfacing with a regulated cGMP environment.
• Understanding of data analysis tools and relevant statistical methods.
• Good understanding of qualification and validation of analytical methods.
• Knowledge of cGMP operations, manufacturing and regulatory requirements for pharmaceutical products especially related to Cell and Gene Therapy

Supervisory Responsibility:

May carry out supervisory responsibilities in accordance with company policies and applicable laws including (but not limited) to interviewing potential candidates, planning studies, assigning tasks, training new and existing team members. Other duties could focus on people management including 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 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.
• Ability to occasionally travel to other sites, vendor locations, and/or conferences.

 

Minimum Qualifications:

• PhD preferably in Virology, Biology, Microbiology, Chemistry, Biochemistry, or a related field and four (4) years relevant experience; OR
• Master's Degree preferably in Virology, Biology, Microbiology, Chemistry, Biochemistry or a related field and eight (8) years relevant experience; OR
• Bachelor's Degree preferably in Virology, Biology, Microbiology, Chemistry, Biochemistry or a related field and ten (10) years relevant experience.

Preferred Qualifications

• Managing Teams at Scientist and Associate levels.
• Previous experience interacting with Contract Manufacturing Organization (CMO) environment and/or being a part of a CMO.
• Degree in Virology, Molecular Biology, Biology, Life Sciences, or 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 **** or ****.

 

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