Senior Director / Executive Director, Biologics Process Development and Manufacturing
To restore cell health and resilience through cellular rejuvenation programming to reverse disease, injury, and the disabilities that can occur throughout life.
For more information, see our website at altoslabs.com.
Our Single Altos Value: Everyone Owns Achieving Our Inspiring Mission.
Diversity at Altos
We believe that diverse perspectives are foundational to scientific innovation and inquiry.
We are building a company where exceptional scientists and industry leaders from around the world work side by side to advance a shared mission.
Our intentional focus is on Belonging, so that all employees know that they are valued for their unique perspectives.
At Altos, we are all accountable for sustaining a diverse and inclusive environment.
What You Will Contribute To Altos
The Altos Institute of Medicine will capture knowledge generated about cell health and programming and develop transformative medicines. We are seeking a highly experienced Biologics CMC leader to join the Technical Operations team within the Institute of Medicine. The candidate will work in a highly dynamic and cross-functional environment that will have close collaboration with the Institutes of Science and span multiple therapeutic areas. The successful candidate will lead process development and manufacturing of AAV gene therapy, mRNA therapeutics and protein therapeutics.
- Lead process development and manufacturing for AAV gene therapy, mRNA and protein therapeutics
- Build a high performing team and establish internal and external biologics capabilities
- Serve as CMC lead on program core teams and manage Contract Manufacturing Organizations to deliver biologics products for nonclinical studies and clinical trials
- Create and foster strong partnerships with Institutes of Science, development sciences, clinical, regulatory, program management, science integrations, business development, legal and finance
- Ensure material specifications, process capabilities, yields, and manufacturing and scale-up strategies are sound for future Altos products
- Lead teams on troubleshooting and data analysis to solve technical problems in manufacturing to ensure manufacturing output and product quality
- Support and lead risk assessments and manufacturing deviation investigations
- Author, review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed.
- As a member of the Tech Ops leadership team, build the Tech Ops organization, processes, systems and infrastructure
- Actively contribute to a team culture that promotes continuous improvement, ownership, professional growth, and inclusion
Who You Are
- PhD in biological sciences or engineering. Minimum 15+ years of Process Development, MSAT, Manufacturing and/or Engineering experience in biotech/pharmaceutical industry. 10+ years of Management experience.
- Highly experienced in AAV gene therapy or mRNA therapeutics process development and manufacturing
- Proficient in cGMP’s and pharmaceutical industry procedures and regulations
- Highly experienced in achieving CMC deliverables through outsourcing to Contract Manufacturing Organizations. Leadership experience in managing diverse project activities with contract CDMO facilities at global locations
- Experienced in leading CMC teams
- A critical thinker with the ability to analyze possibilities and solutions and make pragmatic trade-offs, as well as a big-picture innovator who can identify opportunities and is comfortable with ambiguity
- Strong communication and collaboration skills. Clear and influential communicator. Build effective relationships and partnerships with internal and external stakeholders
- Proven capability to lead, motivate and inspire in a diverse, global, cross-functional structure and commit to diversity, equity, and belonging
- Background in upstream or downstream manufacturing processes preferred
- Senior Director: $289,850 - $392,150
- Executive Director: $333,200 - $450,800
Exact compensation may vary based on skills, experience, and location.
For UK applicants, before submitting your application:
- Please click here to read the Altos Labs EU and UK Applicant Privacy Notice (https://bit.ly/3fHGl98)
- This Privacy Notice is not a contract, express or implied and it does not set terms or conditions of employment.
What We Want You To Know
We are a culture of collaboration and scientific freedom, and we believe in the values of diversity, inclusion and belonging to inspire innovation.
Altos Labs provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Altos currently requires all employees to be fully vaccinated against COVID-19, subject to legally required exemptions (e.g., due to a medical condition or sincerely-held religious belief).
Thank you for your interest in Altos Labs where we strive for a culture of scientific freedom, learning, and belonging.
Note: Altos Labs will not ask you to download a messaging app for an interview or outlay your own money to get started as an employee. If this sounds like your interaction with people claiming to be with Altos, it is not legitimate and has nothing to do with Altos. Learn more about a common job scam at https://www.linkedin.com/pulse/how-spot-avoid-online-job-scams-biron-clark/