Manufacturing Lead Associate (San Carlos, CA)
Sutro has a unique capability that enables new molecular entities to be designed using a hybrid of synthetic and recombinant technologies to create best in class therapeutics in the oncology and auto-immune disease space. Unconstrained by traditional methods of cell-based discovery, we can design and develop targeted medicines by innovating outside the constraints of the cell. Our portfolio includes antibody-drug conjugates, bispecific antibodies, cytokine derivatives and other novel immuno-stimulatory approaches.
- Foster a positive safety culture.
- Oversee manufacturing shift activities, leads Manufacturing on-floor production in absence of Supervisor with expectation of 90% on-floor support.
- Maintain and ensure scheduling of resources and team members.
- Organize and lead manufacturing associates on a day-to-day basis to ensure daily tasks are accomplished in a safe and compliant manner.
- Perform daily shift hand-off and end-of-shift communications.
- Provide clear and timely communication to Supervisor and/or Manager on issues, concerns and metric completion.
- Mentor and assist in the development and growth of the team. Assist in the training of new employees and existing team members.
- Creates, reviews, and approves batch records, standard operating procedures, media/buffer tickets, and forms.
- Utilizes appropriate cGMP principles and policies to solve a variety of problems.
- Troubleshoot and investigate equipment and process problems, and work with others to implement solutions.
- Solves problems in complicated situations through application and integration of analytical skills, creativity and judgment aligned with cGMP manufacturing.
- Leads projects of limited scope; provides training and constructive input to team members.
- Leads closure of process deviations, investigations and CAPAs.
- Instrumental in maintaining manufacturing schedule adherence.
- Impacts business performance and operational efficiency through the delivery of results.
- A minimum of a B.S. Degree in the biological sciences or engineering with three (3) or more years of experience is required and one (1) or more years in a Sr. Manufacturing Associate role in a cGMP environment is recommended.
- Must be knowledgeable of cGMPs and possess a cGMP, compliance, and technical mindset.
- Working knowledge of either cell culture upstream operations or downstream operations (chromatography or tangential flow filtration) and buffer/media preparation operations and equipment. Spray dryer experience a plus.
- Experience in resolving production non-conformances/deviations, implementing corrective and preventative actions, leading improvement projects and initiatives, and validating systems/processes.
- Possess strong leadership, organizational, and technical skills.
- Experience with single-use technology a plus.
- Demonstrates a high level of mechanical and technical aptitude and training.
- Possess strong verbal and written communication skills.
- Ability to follow production schedules.
Sound exciting? Apply today and join our team!
Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, ESPP (Employee Stock Purchase Plan) and stock options.
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.
Salaries listed on jobsites may not be representative of salary ranges at Sutro Biopharma.
Please be advised, inquiries or resumes from recruiters will not be accepted.
Sutro Biopharma, Inc., located in South San Francisco, is a clinical-stage drug discovery, development and manufacturing company. Using precise protein engineering and rational design, Sutro is advancing next-generation oncology therapeutics.
Sutro is dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need. To date, Sutro’s platform has led to cytokine-based immuno-oncology therapies, ADCs, vaccines and bispecific antibodies directed at precedented targets in clinical indications where the current standard of care is suboptimal.
The platform allows it to accelerate discovery and development of potential first-in-class and best-in-class molecules through rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.
In addition to developing its own oncology pipeline, Sutro is collaborating with select pharmaceutical and biotech companies to discover and develop novel, next-generation therapeutics. As the pace of clinical development accelerates, Sutro and its partners are developing therapeutics designed to more efficiently kill tumors without harming healthy cells.