DIRECTOR OF MANUFACTURING

Location
San Diego, California
Salary
DOE + Benefit and Options
Posted
Mar 02, 2018
Ref
DM_RA
Required Education
Doctorate/PHD/MD
Position Type
Full time

DIRECTOR MANUFACTURING 

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento's multimodal multipronged approach to fighting cancer is made possible by its' extensive immuno-oncology platforms, including key assets such as fully human antibodies ("G-MAB™ library"), clinical stage immuno-cellular therapies ("CAR-T"), intracellular targeting antibodies ("iTAbs"), antibody-drug conjugates ("ADC"), and clinical stage oncolytic virus ("Sephrevir®").

We are seeking a Director Manufacturing to support the oncolytic virus program at Sorrento.  The selected candidate would be responsible for the manufacture of clinical materials in compliance with current Good Manufacturing Practice (cGMP) and industry best practices.

Responsibilities

  • Manage a team of professional manufacturing associates for large scale production of oncolytic virus drug substance and drug product
  • Review, approve, and maintain process development materials, equipment, methods for cGMP compliance and scalability
  • Improve recovery, throughput, and scalability to optimize the viral product manufacturing process
  • Develop and maintain accurate work documentation in accord with Sorrento Quality Systems, to include batch records, Standard Operating Procedures, work instructions, log books, Safety Data Sheets, equipment maintenance logs, product specifications, and material specifications
  • Work collaboratively with cross functional teams to ensure on time execution of production schedule and delivery of study drug
  • Effectively communicate results of departmental work to colleagues and management both verbally and in writing

Measurement of Performance

  • Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team
  • Timeliness and accuracy in completion of production campaigns and paperwork (quantity of work)
  • Contributions to projects beyond general responsibilities (quality of work)
  • Identification of problem/risks in areas affecting operations (knowledge/problem solving)
  • Offers suggestions for correcting problems and for improving operations
  • Exercises good judgment in dealing with operational problems
  • Understanding of theory, rationale behind processes performed
  • Demonstrated understanding and adherence to policies, safety procedures and the cGMPs
  • Ability to succeed in a team-oriented environment under very dynamic conditions

QUALIFICATIONS 

The ideal candidate will hold a Ph.D. in microbiology or related discipline, with 4-6 years of industry experience in large scale cGMP production of viral vaccines, viral vectors, or oncolytic viruses. Candidates with an equivalent combination of education and experience will also be considered

  • Must possess a track record of effectively initiating and leading cGMP manufacturing efforts
  • Must possess a strong ability to train team members in accord with cGMP standards and institutional SOPs
  • Must possess strong organization skills, oral and written communication skills, and interpersonal skills
  • Must be a proponent of strong team building and a collaborative work environment

Sorrento offers a competitive salary as well as a comprehensive benefits package including: medical, dental, vision, life and disability insurance, matching 401k, 10 paid holidays, and three-weeks’ PTO, plus stock options.


If this sounds like the right career to fit your personality and interests, we’re looking forward to meeting you. Please attach your CV or resume and note the following job title in the subject line: DM­_RA and email to Jobs@SorrentoTherapeutics.com

Principals only. Recruiters, please don't contact this job poster.

Sorrento Therapeutics, Inc. is an Equal Opportunity Employer