Manager, Process Development - San Diego, CA

A client of ours in San Diego, CA is seeking a Manager, Process Development.
They are a specialty biotechnology company focused on the development and
marketing of cell-based and tissue-engineered products.

Summary
This position is responsible for leading all of the activities related to
process development and improvements in the Company’s human cell culture
processes. Candidate will design, develop and implement production
procedures that optimize manufacturing processes and meet regulatory
requirements. Extensive time is spent preparing process development reports
and communicating to management, interacting with many different internal
departments, outside experts and consultants.

ESSENTIAL DUTIES AND RESPONSIBILITIES
The duties and responsibilities of this position include the following,
although other duties may be assigned.
Evaluate improvements for current manufacturing processes and manufacturing
procedures for new products;
Make recommendations for which process improvements should be pursued,
including those involved in scaling up current manufacturing processes, and
for which manufacturing procedures should be used for new products;
Direct the development and validation of process improvements and
manufacturing procedures for new products, which includes growing human
cells aseptically and preserving and handling the final sterile cell
product;
Oversee the training of production personnel in these process improvements
and manufacturing procedures for new products; and
Lead technical troubleshooting for problems that develop in our current
manufacturing procedures.
Supervisory Responsibilities
This position manages one or two subordinates, who perform laboratory
procedures involved in the development and improvement of manufacturing
processes. The responsibilities include planning, assigning and directing
work; evaluating performance; rewarding and disciplining employees;
addressing complaints and resolving problems. The responsibilities may
include interviewing and hiring employees.

Qualifications
To perform this job successfully, an individual must be able to perform each
essential duty satisfactorily. The requirements listed below are
representative of the knowledge, skill and/or ability required. Reasonable
accommodations may be made to enable individuals with disabilities to
perform the essential functions.
Thorough understanding of Good Manufacturing Practices (GMP) and Quality
System Regulations (QSR). Good working knowledge of clean room practices
and aseptic processing.
Strong training skills: Able to train employees in manufacturing procedures.
Strong communication skills (written & oral): For preparing technical
reports, interacting with peers and presenting reports to upper management.
Leadership skills: Delegate, develop and motivate personnel.
Analytical skills: Able to analyze complex data and make recommendations for
actions.
Technical Skills: Operation of clean rooms; understanding Quality System
Regulations & Good Manufacturing Practices and safely in the workplace.
Planning/Organizational Skills: Able to: take an objective or goal,
determine all of the tasks and milestones required to meet the goal and
organize the tasks with achievable timelines and within acceptable
standards. A detail oriented person that can conceive, research, target and
control reductions in cost and product lead times on both existing and new
products. A problem solver with the ability to manage and motivate
employees.
Implementation Skills: Able to develop broad goals and objectives and
translate them into achievable milestones and action plans. Possess the
capability to follow through with assignments and capable of interacting
with others to do the same. Able to administer and facilitate change.
Strong background and skills in process development and improvement.

Computer Skills: Including working knowledge and experience with Excel and
MRP a plus.
People Management Skills: Good organizational, problem solving,
communication and negotiating capabilities. Able to adapt and administer
change.

Education and/or Experience
Minimum of a BS degree and a minimum of ten years experience in
biotechnology-related (cGMP) manufacturing process development and
improvement, which must include extensive experience in growing mammal
cells, preferably human fibroblast cells, and process validation. A Ph.D.
in process engineering and development a strong plus.
A strong background in cell biology is critical.
Minimum of 3 years managing employees.
Demonstrated experience interacting with other departments and functions.
Experience with regulatory agency audits and knowledge of GMP compliance.

Interested candidates should submit to resumes@...:

1. Brief cover letter/note
2. Resume in Word or Txt format (not PDF please)
3. Salary requirement. If 'open' or 'negotiable', please provide specific
details concerning your salary history.
4. Work authorization (i.e. citizen, h1b, etc)