Senior/Principal Scientist- Vector Development
Location: Cambridge, MA
Apic Bio is committed to finding cures for patients with rare, devastating genetic diseases. The company has a unique THRIVE™ gene therapy platform allowing simultaneous silencing of a toxic gene variant and expression of the wild-type protein. Our current pipeline includes programs for Alpha-1 Antitrypsin Deficiency (Alpha-1, or AATD), genetic Amyotrophic Lateral Sclerosis (ALS), and several undisclosed indications that are not amenable to standard gene therapy approaches.
Apic Bio is seeking a highly motivated Senior/Principal Scientist to join the Process Development Group with a focus on scalable manufacturing technologies. The qualified candidate will be a leader within the group with a strong background and expertise in manufacturing of biologics. Primary responsibilities will include carrying out both upstream and downstream process development activities for the manufacture of pre-clinical and cGMP grade rAAV products, participating in and leading internal productions, writing appropriate documents and carrying out technology transfer to assorted CMOs, and finally participating in cGMP manufacture person in plant activities. The ability to independently organize and design experiments, analyze data and report the results of their and other's work in a concise and well documented manner, and to take the initiative to successfully drive Apic Bio's projects and manufacturing process are all important aspects of the position. As part of the team, the candidate will have the opportunity to acquire new skills in an innovative and fast-paced environment.
- Perform benchtop and preparative separations of rAAV particles from suspension HEK293 cell lines using various filtration, TFF, centrifugation and chromatographic techniques.
- Develop protocols for viral capsid purification using column chromatography / AKTA protein purification systems.
- Complete concentration and diafiltration processes using various TFF systems.
- Provide support for and lead the transfer of developed protocols and downstream processes to internal and external manufacturing parties.
- Write various experimental reports, SOPs, batch records, technology transfer documents and participate in authoring relevant regulatory documents.
- Assist with and lead the production of nonclinical materials at Apic Bio.
- Lead innovation, development and optimization of the Apic Bio downstream platform manufacturing process.
- Lead as Apic Bio's point person for and maintain various external relationships with partners, vendors and CMOs/CROs.
- Interact/ high level of engagement leading Process Development group's IP, conference and publication strategy.
- Degree in chemical engineering, biology, biochemistry, chemistry, biotechnology, or related field
- PhD in a relevant subject matter (e.g. chromatography/filtration of biologics), with a minimum of 4 years industry experience in process development.
- Previous experience working with protein biologics or vaccines is a must, prior experience working with rAAV products desired
- Proficient with the use of AKTA and other chromatography systems, UF/DF systems, and cell filtration devices
- Strong desire to learn multiple new techniques and willingness to work as part of and help lead a larger team
- Significant attention to detail and accuracy in developing, reviewing and following protocols, SOPs, batch records and technology transfer documents
- Ability to be highly productive in a fluid, fast-paced and teamwork-oriented environment
- Prior experience with tech transferring to a cGMP facility is a must, prior experience working with external CMOs desired
- Prior experience managing a team, co-ops or direct reports is desired
- Collaborative and proactive attitude
- Excellent written and oral communication skills