Senior Bioprocess Associate

Astellas Pharma; South San Francisco (CA); On-site; USD 83,000 - 118,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

401(k) match

Job summary

Astellas is seeking a Senior Associate, Technical Development Operations in South San Francisco, CA to participate in upstream and downstream AAV development and production processes within our pilot plant and process development teams. The role focuses on executing operations, maintaining batch records, and supporting process improvements in a fast-paced biotech environment.

The ideal candidate has a relevant degree with lab experience, strong documentation and communication skills, and ability

Qualifications

• Bachelor's degree with 5+ years lab experience or Master's degree with 3+ years lab experience.
• Proficiency with upstream and/or downstream bioprocessing unit operations (Cell Culture, Harvest, Tangential Flow Filtration, Column Chromatography).
• Experience in development of SOPs or batch records.
• Maintain accurate records and effectively manage multiple projects.
• Collaborate in cross-functional teams with internal and external partners.
• Excellent organizational, written, and oral communication skills.
• Strong communicator, able to work independently and in a team.
• Documentation and detailed record-keeping experience; assist in revisions.
• MS Office (Word, Excel, PowerPoint) proficiency.
• Available to work outside normal hours and weekends.

Responsibilities

• Perform operations per internal policies and requirements.
• Enter data clearly into batch records and logbooks.
• Maintain attention to detail in process execution.
• Operate production equipment including setup, processing, and cleaning.
• Address issues with timely corrective actions.
• Attend safety meetings and follow safety procedures.
• Contribute to process improvement plans and drive to completion.
• Collaborate in a team environment to achieve goals.
• Work outside standard hours as needed.
• Conduct process development experiments per plans.
• Oversee non-clinical material production.
• Evaluate new technologies for incorporation.
• Undertake other duties as assigned.

Skills

Bioprocessing

Cross-functional teamwork

Data recording

Documentation

Communication

Education

Bachelor's degree + 5+ years lab experience

Master's degree + 3+ years lab experience

Tools

MS Office

Job description

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Sr. Bioprocess Associate

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose & Scope

The Senior Associate, Technical Development Operations will participate in upstream and downstream areas of AAV development and production within process development and the pilot plant for gene therapy programs and processes. This position is in South San Francisco, CA.

Role And Responsibilities

• Perform all operations as directed per internal policies and other requirements.
• Perform legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in the process
• Maintain a high level of attention to detail with regards to all aspects of process execution
• Operate production equipment, including inspection, set up, processing, and cleaning
• Execute corrective measures addressing any issues in a timely manner
• Attend safety meetings and follow all safety procedures as defined, including maintaining a safe work environment for both self and colleagues. Execute corrective measures addressing any issues in a timely manner
• Ability to contribute to process improvement plans and help drive to completion
• Conduct operations in a collaborative, team environment with a positive attitude to accomplish goals
• Available to work outside of normal business hours and/or overtime as required
• Execute process development experiments following defined experimental plans
• Oversee and execute production of non-clinical material
• Assist in the evaluation and incorporation of new technologies
• Other duties as assigned

Required Qualifications

• Bachelor's degree with 5+ years lab experience or Master's degree with 3+ years lab experience.
• Exhibit proficiency with upstream and/or downstream bioprocessing unit operations (i.e., Cell Culture, Harvest, Tangential Flow Filtration, Column Chromatography)
• Working experience in the development of SOPs or batch records.
• Ability to maintain accurate records and effectively manage multiple projects
• Ability to work productively in a collaborative and cross functional team environment with internal and external partners across multiple scientific disciplines
• Excellent organizational, written, and oral communication skills to convey technical information clearly to diverse audiences.
• Strong communicator with ability to work effectively both independently and as part of a team
• Demonstrated experience in maintaining detailed records and ability to assist in document revisions
• Strong computer skills including MS Office (Word, Excel, PowerPoint)
• Effective problem-solving skills
• Available to work outside of normal business hours and/or weekends as required

Preferred Qualifications

• Experience in process development of cell culture and/or protein purification processes
• Experience working with viruses, especially Adeno-Associated Virus (AAV)
• Experience working in biotech and pharma
• Technical understanding of a biotech manufacturing facility
• Experience with single-use technologies
• Ability to multi-task, be flexible and to thrive in a fast-paced environment, as well as the capacity to handle uncertainty and changing priorities

Location and Working Environment

• This position is based in South San Francisco and will require on-site work.

What awaits you at Astellas?

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide. Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organizational Values and Behaviors

Values: Innovation, Integrity and Impact sit at the heart of what we do.

Behaviors: We come together as 'One Astellas', working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.

Salary Range

$82,880 - $118,400 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)

Benefits

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Company fleet vehicle for eligible positions
• Referral bonus program

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans