January 9, 2019

Manager, Manufacturing

Company Background

Codiak is the leader in the emerging field of exosome therapeutics, working to harness the power of this cellular messenger system to create potentially life-changing medicines. A venture-backed startup founded in 2015, Codiak has rapidly built a proprietary technology platform for exosome engineering and manufacturing that allows for precise targeting of important molecular pathways, opening the door to the development of therapies for cancer and other diseases. Led by an experienced and dedicated team, Codiak has at its foundation a positive and collaborative culture that is deeply rooted in cutting edge science and promotes opportunity for growth.

Position Description

The Manager, Manufacturing will support the planning and execution of internal as well as outsourced manufacturing activities for the production of exosomes, biological molecules, oligonucleotides, small molecules, and drug products. S/he will contribute to the design, building, and continued enhancement of GMP manufacturing capabilities within Codiak. S/he will assist in building and maintaining strong working relationships with technical counterparts at CROs, CDMOs, and within Codiak. S/he will also provide process development support to the process development group when required. This person will report to the Director of Manufacturing with extensive interaction with the process development group.
Main responsibilities include developing batch records and manufacturing reports, assisting in review of GMP product characterization, validation, release and stability data, and managing outside GMP manufacturing facilities to execute activities in a timely manner. A strong technical background in process development and experience in a GMP manufacturing facility are a must. This position will require some hands-on laboratory time.

Responsibilities

  • 1. Assist in the development and scale up of robust cell culture and purification processes based upon quality by design (QbD) concepts that address critical quality attributes and process parameters. Processes must ensure product quality, afford satisfactory yields, and allow for transferability to commercial manufacturing operations;
  • 2. Manufacture of biologics drug substance, payloads, and drug product to support non-GLP and GLP nonclinical studies, development of functional and biophysical analytical methods for characterization and quality control, design and development of drug product, and production of CTM (cGMP) for clinical evaluation;
  • 3. Assist in the preparation of CMC documentation for regulatory and/or patent filings;
  • 4. Establish and maintain an understanding of current trends and emerging upstream and downstream process technologies to ensure that manufacturing team is at forefront of biologics and small molecule development;
  • 5. Author, review and approve of phase-appropriate master batch records, executed batch records, and reports;
  • 6. Review of process and manufacturing data, including technical review of change control documentation and reports, deviations, and OOS;
  • 7. Assist in developing manufacturing strategy, designing manufacturing facility, and enabling continuous improvement in manufacturing resources;
  • 8. Support all manufacturing activities to CROs/CMOs for the production of payloads (including oligonucleotides and small molecules), exosomes, and drug product;
  • 9. Collaborate with process development on designing and optimizing upstream and downstream exosome manufacturing processes;
  • 10. Work collaboratively with Upstream PD, Downstream PD, Analytics, and Research groups to develop an increased depth of knowledge of processes and identify improvement opportunities;
  • 11. Perform document writing, including SOPs, qualifications, batch records, data interpretation, presentation, statistical analysis and trending;
  • 12. Assist in the preparation of CMC documentation for regulatory and/or patent filings;
  • 13. Participation in decision-making processes within the project team by actively engaging in scientific and technical discussions;
  • 14. Resolve technical problems through scientific understanding, options assessment, and application of innovative solutions;

Qualifications

  • BS and/or MS degree in chemistry, biochemistry, (bio)chemical engineering (or other relevant physical or life sciences discipline);
  • At least 6 years work experience in a GMP environment;
  • Background in the support of GMP manufacturing campaigns, technology transfer, process development, and process optimization;
  • Background in production of both biologics and small molecules;
  • Background in manufacturing facility design and management;
  • Direct experience in authoring and review/approval of technical protocols and reports, deviations, and investigations;
  • Strong knowledge of cGMP/ICH/FDA/EU regulations;
  • Experience with writing Quality CMC sections for regulatory filings;
  • Work with minimal supervision, demonstrated ability to troubleshoot, quickly design and execute thoughtful experiments leading to innovative solutions;
  • Strong work ethic, strives to learn new things, and capable of working independently and in a collaborative environment;
  • Excellent communication, project management, and presentation skills (oral and written);
  • Proven track record of being personable, energetic, responsive, empowering, inclusive, action-oriented, accountable, and an effective communicator

Compensation & Benefits

Codiak provides competitive compensation and benefits package that support and reward the contributions of each member of the team.

Apply Today

Those interested in joining the team effort at Codiak BioSciences to advance the nascent and exciting field of exosome technology into therapeutics with transformative potential are invited to email their CV.

About Codiak

Recent discoveries have demonstrated that exosomes derived from normal cells can act as a potent and safe delivery system for multiple therapeutic payloads. These small vesicles, which leave cells and travel throughout the body, can mediate dramatic effects in animal models of disease.

We are developing a broad platform for the delivery of macromolecules to the cytoplasm of diverse cells and tissues, to create a proprietary pipeline of novel, targeted medicines for diseases with high unmet medical need. The company’s technology exploits the natural propensity of exosomes to transmit macromolecule payloads between cells to create a pipeline of drugs across a broad range of diseases, including those associated with currently “undruggable” targets. While our initial focus is on oncology/immuno-oncology, this approach also offers significant potential in hematology, neurology and gene therapy and other therapy areas.

We are now producing drug candidate exosomes using the engExTM platform, our novel therapeutic engine for exosomes. We tailor exosomes to express molecules on their surfaces and/or deliver specific cargo inside. This affords us the flexibility for designing proprietary drug candidates; exosomes can be mixed and matched into rational and targeted combinations with the potential for a broad therapeutic platform.

As of December 2017, Codiak has raised a combined $168.5M in Series A-C financing. The company maintains partnerships with academic exosome labs and has multiple paths to clinical and commercial success through the breadth of the company’s research, strength of its IP position and proprietary innovation behind its production capabilities.

Inspired Employees

Codiak’s CEO and first employee Doug Williams, Ph.D., (former EVP of Biogen R&D, CEO of ZymoGenetics) espouses the belief that inspired employees create great science. Employees treat the company as if it was their own and report that there is “direct and respectful communication,” and “trust that teammates will do the right thing and never compromise integrity.”

Named one of 11 disruptive startups “on a do-or-die mission to launch new meds” by Endpoints News in January 2018, Codiak is in the heart of Boston’s biotechnology hub at 500 Technology Square in Cambridge, Massachusetts.

Codiak BioSciences is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.