Senior Technical Manager - Analytical Development

Roche; South San Francisco (CA); Vor Ort; USD 147.000 - 272.000; Vollzeit

Benefits dieser Stelle

Relocation assistance

Discretionary annual bonus

Zusammenfassung

Genentech in South San Francisco, CA, is seeking a highly motivated leader to guide the flow cytometry analytical development team in cell therapy programs. You will establish robust, state-of-the-art assays and collaborate across Process Development, QC, Manufacturing, Regulatory Affairs, and other functions to ensure product quality and process performance.

You will mentor three scientists, apply QbD and cGMP principles, and drive method transfer to GMP QC and external partners.

Qualifikationen

• PhD in Biological Sciences or related field; 3+ years in biotech/pharma (cell therapy) if PhD, or MS/BS with 9+ years.
• Proven supervision and mentoring of analytical development teams.
• Strong knowledge of cGMPs, ICH, FDA framework and QbD principles.
• Experience with DOE and statistical methods for method lifecycle management.
• Excellent written and verbal communication; able to author CMC documents.

Aufgaben

• Lead studies for development of robust multicolor flow cytometry methods and cell-based assays.
• Represent analytical development in CMC and program meetings.
• Manage method transfer to GMP QC and external partners.
• Foster collaboration with cross-functional groups to support method development and product characterization.
• Provide training and mentorship to other teams on flow cytometry methods.
• Stay current with industry trends and evaluate platforms and literature.
• Draft technical reports, SOPs, and test protocols.
• Lead a team of analytical development scientists toward program milestones.

Kenntnisse

Supervision

Mentoring

DOE

Statistical methods

Regulatory communication

Cross-functional collaboration

Adaptability

Ausbildung

PhD in Biological Sciences

MS/BS with 9+ years experience

Tools

Multicolor flow cytometry

Cell-based assays

qPCR

ddPCR

ELISA

NGS

Jobbeschreibung

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Genentech!

The Opportunity

We are seeking a highly-motivated individual with a breadth of analytical development expertise to provide scientific and technical leadership to the flow cytometry analytical development team.

The successful candidate will be responsible for establishing analytical methods and implementing best practices in support of cell therapy process and product development including the development and implementation of best-in-class analytical testing strategies to control and characterize products. Operating in a cross-functional and dynamic environment, the individual will partner with Process Development, Quality Control, Manufacturing Sciences and Technology, Product Development, Regulatory Affairs, and Manufacturing teams.

The ideal candidates should have experience managing daily operations of a team and implementing analytical testing methods that are compliant with regulatory requirements. This role leads a team of three Technical Development Scientists.

Key Responsibilities

• Lead and execute studies for the selection and development of robust, state-of-the art multicolor flow cytometry methods and cell-based assays to monitor final product quality attributes and process performance.
• Represent analytical development team in CMC and program meetings to facilitate the completion of goals
• Manage method and analytical technology transfer to the GMP QC team and external partners
• Enable a collaborative work environment with key groups to support analytical method development as well as the characterization of cell therapy products
• Provide training, mentorship, and support to other teams developing flow cytometry methods, as a technical expert
• Maintain knowledge of industry trends and critically evaluate analytical technology platforms, single cell analysis technologies and scientific literature in order to contribute maximally to cell therapy analytical development efforts.
• Draft technical reports, standard operating procedures, and test protocols in support of analytical development.
• Enable successful completion of key program milestones through individual contributions and supervision of team of analytical development scientists

Who You Are

• Ph.D. in Biological Sciences or other related field with 3+ years of relevant experience in the biotech and/or pharmaceutical industry preferably in cell therapy. MS/BS considered with 9+ years of relevant experience.
• Proven supervision and mentoring of analytical development teams, preferably for cell therapy products
• Strong background applying QbD principles along with practical knowledge of relevant cGMPs, ICH, and FDA regulatory framework expectations.
• Proficiency in relevant statistical methods including application of design of experiment (DOE) for development and lifecycle management of analytical methods
• Excellent interpersonal, verbal, and written communication skills including experience authoring CMC regulatory documents
• Proven hands-on expertise with multicolor flow cytometry, cell-based assays, or complementary platforms (e.g., qPCR, ddPCR, ELISA, NGS)
• Thrives in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
• Expertise in stem cell biology, immunology and/or cancer biology is strongly preferred

Relocation benefits are available for this job posting.

The expected salary range for this position based on the primary location of South San Francisco, CA is $146,500 - $272,100. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company’s policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.