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Department: Operations

Job Title: Sr. Director, Process and Analytical Sciences, E0872-A

Description:

Lead XOMA's effort to remain on the leading edge of processing and analytical technology and establish those leading edge technologies within the company.  Take responsibility for developing the strategic direction of XOMA's process and analytical sciences efforts to meet the needs of the company's short and long-term objectives.  Ensure the P&AS groups are aligned with company objectives, both near-term and long-term.  Represent XOMA with outside partners and prospective partners, as needed.  The strategy should encompass development of complex processing/methods for the fermentation (e.g. medium development, new cell line technologies), recovery, and purification and their potential for large scale production.  Evaluate new technologies at small scale and choose the most promising for scale-up and potential manufacturing.  Work closely with the scale-up and manufacturing staff to coordinate timely execution of large scale experiments.  Provide technical support services for scale-up and manufacturing department(s).  Develop analytical tools and methods for adequately characterizing XOMA's processes.  Develop robust methods that allow for efficient transfer to Quality Control.  Interact with internal and external functional areas to resolve and negotiate process and analytical development issues.

 

ESSENTIAL DUITES:

  • Develop a strategy document that details the strategic direction for XOMA's process and analytical development activities. Document to include the plan for assessing new process and analytical technologies within XOMA's labs.
  • Direct process development activities for medium development, cell culture, fermentation, recovery, and purification, and transfer processes to manufacturing as needed to meet project requirements.
  • Direct analytical development activities for biochemical, bioassay and analytical development and transfer to QC as needed to meet project requirements.
  • Determine analytical technologies necessary to efficiently develop and support new process technologies.
  • Specify, design, order, and install process and analytical instrumentation and equipment.
  • Coordinate with fermentation and recovery/purification scale-up staff to carry out large scale experiments that are meant to provide feasibility for new technologies at large scale.
  • Support process development and scale-up efforts with analytical characterization of the product and process.
  • Coordinate the efficient transfer of developed test methods to QC.
  • Establish and oversee plans to achieve strategic short-term and long-term goals.
  • Lend technical and analytical support to manufacturing operations. Design and carry out scale down experimentation to support manufacturing (e.g., virus removal validation studies). Work with scale-up staff to implement new process and analytical technologies.
  • Develop employees to meet the strategic process and analytical sciences objectives.
  • Prepare and review CMC sections of regulatory submissions for scientific integrity.
  • Exercise independent judgment on the evaluation of new processes, analytical methods, equipment, techniques, and complex technologies to improve the quality and efficiency of our existing operations to support corporate objectives.
  • Schedule work flow in conjunction with collaboration and internal product programs.
  • Accountable and responsible for managing timelines, deliverables, departmental budget, and overall success of the department.
  • Responsible for the overall direction, coordination, and evaluation of the process and analytical sciences unit.
  • Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

 

OTHER DUTIES:

  • Other projects as assigned.

Comply with XOMA's Policies and Procedures

 

Job Requirements:

Education and/or experience

  • Ph.D. in Biochemistry, Chemical Engineering or other scientific discipline with 10-15 years of industrial experience in bioprocessing and analytical development for therapeutic protein products or equivalent; or equivalent combination of education and experience.

 

Special skills/knowledge

  • Hands-on and supervisory experience in scaled-up biotechnology processes.
  • Knowledge of and experience with bioprocess and analytical equipment and instrumentation.
  • Knowledge of new process and analytical technology to enhance process efficiency (e.g., new cell lines, in-line testing, medium development, etc).
  • Ability to interact with all disciplines within biopharmaceutical processing, analytical and support areas.
  • Effective communication skills.
  • Knowledge of cGMPs for parenteral biopharmaceuticals.
  • Knowledge and experience with regulatory documentation including batch records, SOPs, validation protocols, and reports.

 

Language skills

  • Ability to read, analyze, and interpret common scientific and technical journals.
  • Ability to respond to common inquiries or complaints from other departments, regulatory agencies, or members of the business community.
  • Ability to write speeches and articles for publication that conforms to prescribed style and format.
  • Ability to effectively present information to other employees or groups of management.

 

Mathematical skills

Ability to work with complex mathematical concepts such as probability and statistical inference and the ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

 

Reasoning ability

  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

 

Physical demands

  • While performing the duties of this job the employee is regularly required to stand, walk, sit, talk or hear, use hands to handle, work at a video display terminal.
  • Specific vision abilities required by this job include color vision, close vision and the ability to adjust focus.

 

Work environment

  • While performing the duties of this job, the employee is occasionally exposed to toxic or caustic chemicals, or radiation or biohazardous waste.
  • The noise level in the work environment is usually moderate.
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and ability required. Reasonable accommodations may be made on a case by case basis.

To apply for this job, please send us an e-mail with your resume and cover letter.