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GenCure: Sr. Scientist Process Development And Manufacturing

GenCure

This is a Full-time position in San Antonio, TX posted August 24, 2021.

Our organization is unique in that we are a nonprofit community resource that saves lives by working with volunteer donors to provide the highest quality blood & tissue components to patients.

By using cutting-edge technology, our team of dedicated professionals has helped save hundreds of thousands of lives for more than 35 years.

Over 200,000 components of life-saving blood and tissue from volunteers throughout South Texas are collected and tested each year.

We are internationally recognized for the quality of our services and research.

Donors are essential because patients are in constant need of blood.

blood components, and/or tissue.

It’s about life!

Share our excitement and join our team!GenCure, a subsidiary of BioBridge Global, applies advances in regenerative medicine to help heal patients suffering from trauma, disease or the aging process.

Using processed tissue and cell-based therapies, GenCure works to connect needs with solutions.

GenCure is both a direct supplier to healthcare providers and a partner with commercial and non-profit organizations providing regenerative medicine treatments to patients.

General SummaryProvide high level support and leadership for GenCure Process Development and Cell Manufacturing including: supervising junior staff, providing a leadership role for technology transfer, GMP process and analytical methods development, GMP manufacture and QC testing as well as managing relationships with outside vendors and Contract Research and Testing Organizations.

This position requires strict attention to detail, high quality customer service skills and the ability to instill these qualities onto other members of the team.Commit to and abide by the character of BioBridge Global’s Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE).

Support, communicate and reinforce the mission and vision of the enterprise.Provide world class customer service by capturing and being responsive to the voice of the customer (internal or external, including donors for select positions) through multiple feedback channels in order to resolve issues and drive satisfaction in accordance with the BBG customer engagement, feedback, and complaint processes.It is essential that the incumbent have a valid driver’s license and be at least 21 years old with a good driving record to meet organization driving standards.

Major Duties and Responsibilities Essential Tasks Lead efforts in the development of cGMP-compliant, clinical-scale manufacturing processes for cell therapy clinical materials.

Independently manage technology transfer and process development activities for processes by collaborating with client technical teams.

Following approved technology transfer protocols; this person will optimize existing research-scale manufacturing processes and develop them for clinical-scale GMP manufacturing.

This includes generation of all relevant documentation.Lead efforts in the development and phase-appropriate validation of analytical test methods for the characterization and release testing of cell therapy clinical materials.

Independently manage technology transfer of research analytical methods by collaborating with client technical teams.

Following approved technology transfer protocols; this person will optimize existing methods and validate them as appropriate for QC release testing.

This includes generation of all relevant documentation.Following FDA GMP regulations and guidelines, this individual will collaborate in the clinical-scale GMP manufacturing, in process testing and QC release testing of cell therapy products.

This will include the supervision of junior staff as well as operational scheduling of various activities; including raw materialsprocurement, development activities, manufacturing events, product testing, facility cleaning and environmental monitoring, calibration, preventative maintenance and validation activities.Manage relationships with outside raw material vendors and contract testing laboratories.

Establish and maintain relationships with technical representatives concerning raw material procurement and GMP production and testing of clinical trial materials.

Represent the cGMP Facility to outside contractors and be able to respond to their questions independently and accurately.

Monitor spending to be sure budgets and timelines are met.Responsible for authoring all relevant technical reports detailing process and analytical methods transfer, production and testing of development batches, preclinical safety/toxicology batches and GMP-grade clinical batches.Performs other duties as assigned.

EducationRequires a Master’s Degree from an accredited college or university.

The required degree is in a scientific orengineering discipline is required with experience in mammalian cell culture and analytical biochemistry.

Prefer a Doctoral Degree (e.G., Ph.D.

or equivalent) from an accredited college or university.

ExperienceIf Master’s Degree attained, requires ten or more years experience in mammalian cell culture and analytical biochemistry.If PhD is attained, requires three or more years of experience in mammalian cell culture and analytical biochemistry.

KnowledgeMust obtain a working knowledge of regulatory/quality requirements and perform within all Standard Operating Procedures (SOPs) and policies.Must maintain a knowledge of cGMP (current Good Manufacturing Practices).Must maintain familiarity of regulatory/quality compliance, to include FDA, EU, ISO, GHM, cGMP, OSHA, etc.Must have a specific understanding of the following subject matter areas is strongly preferred: cell biology analytical development, mammalian cell culture.Must have a working knowledge of tissue and cell culture.

SkillsMust have excellent interpersonal and public speaking skills.Must be capable of operating motor vehicles in all types of weather conditions.Must demonstrate the ability to solve technical and/or clinical problems with biotechnology-based solutions required.Must have excellent hands-on laboratory skills AbilitiesMust be able to commit to project delivery timelines and budget.Must be able to keep information confidential.Must be energetic, enthusiastic and have a team-oriented leadership style.Must be neat in appearance and well groomed.Must be professional, detail oriented, self-motivated, innovative, creative, assertive, organized, communicative, and have the ability to work independently.Must maintain a good working rapport with co-workers.

Working EnvironmentWorks in a well-lighted air conditioned and heated laboratory/department.

May be exposed to electrical, mechanical and chemical hazards and other conditions common to a laboratory environment.

May be exposed to blood borne pathogens and other conditions common to a clinical laboratory environment.

May have bodily exposure to refrigerator/freezer temperature, especially hands and face.

Will work extended hours during peak periods.

May be required to work any time of the day, evening or night during the week or weekend.

Ability to use personal motor vehicle for company business required.

Physical RequirementsWill sit, stand, walk, and bend during working hours.Requires manual and finger dexterity and eye-hand coordination.Required to lift and carry relatively light materials.Requires normal or corrected vision and hearing corrected to a normal range.Must be able to drive on behalf of the organization.

We invest in our people by offering competitive compensation, excellent benefits, and the opportunity to work with the first blood center in America to receive the ISO 9002 accreditation!All Full Time Positions Qualify for an Affordable and Competitive Benefits Package to include:Competitive salary100% Employer Paid Life InsuranceVariable Compensation Plan100% Employer Paid Long-term Disability PlanPaid Time Off (PTO)100% Employer Paid AD& DExtended Illness Benefits (EIB)100% Employer Paid Employee Assistance ProgramShift DifferentialsGroup Health Medical Plan w/prescription coveragePaid HolidaysVariety of Voluntary Supplemental InsurancesLeaves of AbsenceVoluntary Dental CoverageEducational Assistance ProgramVoluntary VisionProfessional Development Plan (PDP)100% Employer Paid Pension Plan GenCure, a subsidiary of BioBridge Global, is proud to be an Equal Opportunity Employer committed to providing employment opportunities to minorities, females, veterans, and disabled individuals.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, genetic data, sexual orientation, gender identity, or any other legally protected characteristics.

For more information about your EEO rights as an applicant under the law, please click here.

GenCure maintains a Tobacco & Drug-Free Workplace.

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