The Director/Sr. Director of Manufacturing will be responsible for defining the strategy and assuring successful implementation of biologics manufacturing processes within Synageva’s clinical and commercial manufacturing supply chain. The candidate will be responsible for implementation of new processes, technical management of existing processes, and continuous support of manufacturing through commercial and life-cycle management. Manufacturing processes include Drug Substance, Drug Product and support of the clinical team for packaging and labeling activities for our ongoing clinical trials. The Director of Manufacturing will manage our external manufacturing contract suppliers (CMO’s) for clinical manufacturing as well as commercial launch and re-supply. The candidate will be responsible for developing the manufacturing organization to support successful launch and supply for a multi-product global supply chain. The leadership and strategy provided by the candidate will be critical to the assurance of successful manufacturing readiness and successful clinical supply and launch.
The candidate for this position will interact closely with process development, supply chain, and the quality organization in order to ensure product supply, and continuous improvement of our supply chain in non-clinical and clinical manufacturing.
The successful candidate will be responsible for achieving the following objectives:
Implementation of robust and scalable manufacturing processes (complex glycoprotein biotechnology products).
Development and Oversight of a Manufacturing Technical Support (MTS) function for all clinical and commercial programs, including: management of external contract development organizations and internal process engineering.
Support of manufacturing investigations, and regulatory submissions.
Management of Contract Manufacturing, contracts, resources and budget.
Management of the direction and prioritization of the MTS team capable of meeting manufacturing process objectives.
Update and recommend to company’s senior management with regard to the status of objectives, projects and goals, particularly as they relate to cross-functional business objectives
Work closely with regulatory staff to assure development of submissions
and ongoing compliance with those submissions and regulatory
Assure the development and review of high quality technical reports
required for method development, validation, stability, and
Maintain current state of the art knowledge and evaluation of emerging
technologies for analysis of recombinant glycoproteins with emphasis on
support of robust comparability exercises and rigorous characterization
of products in development.
Candidate should have a PhD or equivalent with greater than 10 year’s
industry experience in: analytical, biophysical, biochemistry,
molecular/cell biology, chemical engineering, or related field.
10+ years of supervisory and/or management experience.
Experience with or knowledge of one or more of the following, as
appropriate: separation sciences, process engineering, purification
development, chromatography, bio-separation, liquid or lyophilized drug
Strong leadership skills and substantial experience with manufacturing of
biologics, with experience in BLA approvals, post approval inspections
and technology transfer is preferred.
Understanding of regulatory requirements in drug product and drug
product manufacturing including IND and BLA submissions, process
validation, including virus validation preferred.
Candidate must have experience with manufacturing process
development of glycoproteins in a regulated environment.
Industry experience with providing a technical role in the support of
approved commercial products is strongly preferred.
Understanding of worldwide of cGMP and process requirements in early,
late-stage and commercial manufacturing is preferred.
Excellent verbal and written communication skills, detail-oriented
personality, and ability to work productively in an interdisciplinary team
Ability to work successfully with contract manufacturing and research
Commitment to operational excellence.
Synageva BioPharma is a publicly traded biopharmaceutical company with
headquarters, research and development facilities in Lexington, MA, and research
and production facilities in Athens, GA. Synageva is dedicated to developing novel
orphan treatments for rare diseases. Our lead program, sebelipase alfa, an
enzyme replacement therapy for LAL Deficiency, is in global clinical trials and has
been granted orphan designation by the FDA, the European Medicines Agency,
and the Japanese Ministry of Health, Labour and Welfare. LAL Deficiency is a rare,
serious and devastating disease that leads to significant morbidity and mortality.
Synageva has additional orphan products in various stages of preclinical
development. To ensure that these therapeutic candidates reach patients in
need, Synageva has recruited a team with a proven track record of manufacturing, discovery, development, and commercial success within rare diseases.
Our mission is to deliver breakthrough medicines globally for patients suffering from devastating diseases. Achieving this will result in a sustainable business that can continue to positively impact the lives of patients and their families, healthcare providers and our employees. Our success depends upon our ability to seek and retain principle-minded individuals who share our integrity, drive, energy and passion.