Director of Purification Development

JOB DESCRIPTION

JOB TITLE: DIRECTOR OF PURIFICATION DEVELOPMENT DEPARTMENT: R&D SERVICES
REPORTS TO: CTO
FLSA STATUS: EXEMPT
GENERAL SUMMARY:

The Director of Purification Development will oversee all the scientific, engineering and client-facing aspects of protein purification and vector purification process development, process demonstration, scale-up/down, process characterization and process validation support. The candidate is required to guide the team to follow current best practices in process development strategies, documentation and equipment/facility management and relevant business systems to ensure on-time and right-first-time delivery of client milestones. The candidate is required to have knowledge of GMPs, control strategy, scale-up and manufacturability for large molecule APIs. The candidate will be assigned strategic initiatives to lead within his/her department resulting in measurable continuous improvements in services, capabilities, quality and capacity. Development of department performance indicators and monthly reporting will be required. This candidate will also handle all administrative and managerial duties for the group including goal deployment, goal tracking, training, lab hygiene, and timesheets. The candidate will be considered the leading thought leader in large molecule APIs for the site.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Oversee all the scientific and engineering aspects of process development, process demonstration, scale-up/down, process characterization and manufacturing technical support for department of large molecules including but not limited to monoclonal antibodies, IgG1, IgG2, IgG4, IgM, antibody fragments, bi-specifics, fusion protein in early, mid and late stage clinical development

• Use sound scientific and engineering criteria to design and develop manufacturing processes, identify and execute process improvement strategies and ensure successful scale-up and tech transfer of biologic products

• Follow all client contractual obligations and deliver client milestones on-time, on-budget and right-the- first time

• Participate in project meetings, prepare and/or review protocols and project reports

• Ensure efficient utilization of equipment and personnel

• Manage on-going external collaborations and alliances to target endpoints

• Generate technical and scientific content for corporate marketing purposes and attend scientific

  conferences to speak on behalf of The Company

• Leverage deep subject matter expertise, troubleshooting skills, design-of-experiments and equipment

  knowledge for successful execution of multiple client processes

• Help to evaluate new client project opportunities

• Lead client-side interaction and set standards for quality of reporting and presentation

• Responsible for maintaining state of the art knowledge in upstream cell culture process for biologics

  production

• Establish a close collaboration with upstream development, analytical development, manufacturing and

  MST groups

• The ability to supervise and develop others as well as lead project teams

• The ability to effectively work in teams, both departmental and cross-functional

  SUPERVISORY RESPONSIBILITIES:

  This position may involve supervisory responsibilities of other purification development scientists and associates.

  JOB REQUIREMENTS:

• Education and experience –PhD degree in an applicable scientific discipline such as biochemistry, microbiology, chemical engineering or related discipline is a requirement for this position

• Previous large biopharma experience in a technical role is a requirement for this position

• 3+ years working in a viral vector process development technical capacity is a requirement for this

  position

• Minimum required applicable experience is 10 years for a PhD (hands-on experience in protein

  purification development) with 5 years’ experience working in a management capacity. Experience may be a combination of post-doctoral, academic, or biotech industrial setting. Biotech experience is preferred.

• Demonstrated expertise with a range of laboratory techniques associated with clarification, purification, ultra-filtration/diafiltration and formulation development is required.

• A broad range of experience with microbial and mammalian products

• Ability to define problems, collect and analyze data, and draw conclusions.

• Able to work in a semi-independent manner under the supervision of the Vice President of Process

  Development

• Good written and oral communication skills.

• Strong computer skills including MS Word, Excel, and PowerPoint.

  PHYSICAL DEMANDS:

  While performing the duties of this job, the employee is frequently required to stand; sit and talk or hear. The employee is occasionally required to walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl.

  WORK ENVIRONMENT:

  While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually moderate.