Manager, Process Development - San Diego, CA
Manager, Process Development for a San Diego, CA based 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
w/ 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 from workwondersstaffing.net:
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)
