Sr. Manager, QA Lot Disposition
Description
Position Overview
Sutro Biopharma, Inc. is looking for a dynamic quality customer-focused professional with working experience on product lot release of internally and externally produced products including raw materials. This individual will have the ability to handle multiple priorities and meet CMC deliverables as one of the SMEs for product disposition.
This position is for a 6 to 12-month duration with a possible extension based on business needs.
Responsibilities
This individual will be responsible for supporting external supply chain cGMP operations at Sutro Biopharma’s and internal cGMP Operations as needed and will, at a minimum, include:
- Perform Lot Release Disposition of Internally and Externally produced products.
- Represent QA team leadership to respond to CMC deliverables on product disposition externally and in some cases, internally
- Coordinate with External Quality Assurance to compile and review all documentation to perform Quality Release of Externally produced Products
- Assist in the completion and maintenance of CMO/CTO Quality Agreements
- Actively support the development, implementation, and maintenance of Sutro quality management systems & applicable SOP’s
- Perform reviews of cGMP documentation, both at Sutro and contract organizations.
- Review and approve completed batch documentation for cGMP production, including QC documentation of release and in-process testing
- Lead investigation and resolution of cGMP or procedural compliance failures, as well as work with staff from other departments to resolve compliance issues found during the Quality review.
- Release raw materials and batches/lots for further manufacturing, clinical trials, and commercial distribution
- Oversee and perform training of personnel to ensure compliance and conformance to Sutro’s requirements
- Develop, apply, revise, and maintain quality assurance protocols and methods for processing materials into partially finished or finished products
- Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary
- Participation in the ERP and Quality System implementation, training, and maintenance activities
- May ensure compliance to in-house and/or external specifications and standards, (i.e. GLP, GMP, ISO, Six Sigma)
This individual will be expected to effectively follow Sutro Biopharma’s SOPs and policies, and cGMP compliance regulations. Additionally, he/she should be able to independently manage review times to meet Sutro’s priorities and communicated timelines.
This individual may be asked to travel on behalf of Sutro Biopharma to support business operations that involve contract manufacturing. Anticipated travel is approximately 5-10%.
Key Internal and External Collaborations and Interface:
- Internal Collaborations – Manufacturing, Quality Control, Quality Operations, Process Development, Analytical Development, Supply Chain, Regulatory Affairs, Alliance Management, among others
- External Collaborations – Contract Manufacturing Organizations (CMOs), Contract Testing Organizations (CTOs), Partnered Program Companies
Qualifications:
- 10+ years of industry experience with 8+ years experience in Quality Assurance/Quality Systems related experience in a cGMP pharma/biologics regulated manufacturing environment is required
- Possess a working knowledge of 21 CFR FDA, EU and ICH guidelines
- Bachelor’s degree or higher in a relevant scientific area is strongly preferred
- Relevant Quality Systems experience including Supplier and CMO/CTO Management, Raw Material Review Board Team Management, Change Control, Documentation Control, Training and Raw Material/Final Product Release
- Skilled in evaluating and implementing solutions for regulatory compliance guidelines
- Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities
- Knowledge and ability to sufficiently train others on regulatory compliance issues pertaining to external requirements
- Strong interpersonal skills and ability to work with others in a positive “can do” and collaborative manner
- Balanced decision making that demonstrates critical thinking
- Able to establish priorities and maintain progress even under uncertain circumstances
- Strong verbal and written communication skills are essential
- Strong communication, prioritization and organizational skills
- Requires thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies
- Ability to utilize multiple word-processing and database applications
Sound exciting? Apply today and join our team!
Sutro Biopharma, Inc. encourages all colleagues to be fully vaccinated for COVID-19 prior to the first date of employment.
As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together.
We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third-party agencies.
The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California based locations will be $170,000 - $175,000. The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry and education.
About Sutro Biopharma
Sutro Biopharma, Inc., is a clinical-stage company relentlessly focused on the discovery and development of precisely designed cancer therapeutics, transforming what science can do for patients. Sutro’s fit-for-purpose technology, including cell-free XpressCF®, provides the opportunity for broader patient benefit and an improved patient experience. Sutro has multiple clinical stage candidates, including luveltamab tazevibulin, or luvelta, a registrational-stage folate receptor alpha (FRα)-targeting ADC in clinical studies. A robust pipeline, coupled with high-value collaborations and industry partnerships, validates our continuous product innovation. Sutro is headquartered in South San Francisco. For more information, follow Sutro on social media @Sutrobio, or visit www.sutrobio.com.