Our mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare investors, and pharma company partners, who share in our commitment to bettering the lives of patients and realizing a world where we make brain disorders history
The Senior Manager, Manufacturing QA plays a key role in supporting the Manufacturing process including process validations and process performance validations, and technology transfers at and between CMO Vendors. This role exercises a high level of critical thinking and influence to drive successful and compliant manufacturing operations and ensure Alector’s capability to provide drug products to clinical trials and patients that meet all regulatory requirements and specifications.
Essential responsibilities include:
- Cooperate with internal and external partners to ensure reliable and compliant manufacturing processes of Alector’s products.
- Establish and oversee governance and reporting to ensure timely and thorough measurement, tracking and problem solving of Manufacturing and related activities.
- Bring technical expertise to identify technical, operational, and organizational gaps and drive innovation.
- Use product and process understanding to drive the resolution, review, and approval of quality events (such as deviations, change controls and CAPAs) related to manufacturing, process validation or technology transfer activities.
- Act as “Person-in-Plant” during manufacturing campaigns at Alector’s contract manufacturing organization to provide real-time feedback and problem resolution.
- Conduct technical assessments of CMO facilities and participate in audits to ensure adequate risk mitigation and protection of Alector’s interests.
Skills & Experience:
- Bioengineering or relevant scientific discipline with at least 5 years of experience in manufacturing and process development.
- Strong background in cGMP manufacturing
- Experience with DS and DP manufacturing, Technology Transfer, CMC, Process Validation for Biologicals
- Excellent written and oral communication skills
- Proven experience successfully leading cross-functional manufacturing initiatives.
- Ability to provide “on your feet” problem solving as well as communicating effectively with a different mix of partners.
- Leadership experience in Biologics Operations, MSAT, Technology Transfer, Process and plant start up, Portfolio management and continuous improvement.
- Ability to deliver results through team performance, agility and problem solving, strong drive for efficiency and continuous improvement, ability to establish partnerships with a broad range of partners.
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At Alector, our vision is bold, people are our priority, and our values are at the core of everything we do. Our dynamic and flexible environment encourages our teams to experiment, take ownership of decisions, and question convention to solve complex problems. We value shared wins, perseverance, and a growth mindset, which drives us forward, together.
Among the things you'll discover at Alector from your very first day are our committed and driven colleagues, a bold company vision, and new, modern offices designed to inspire innovation and collaboration in South San Francisco, right at the heart of Biotech Bay. Our benefits are thoughtfully designed around Alectorians and their loved ones and include flexible hybrid work options, competitive compensation, and comprehensive and unique benefits that enhance your health and well-being. Come join us!
We believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.
