• Job Description

  Req#: 27519

  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.

  Job Title: Director, Operations Support, GenCure

  Revision: 0000

  Job Code: 704459

  Shift: Monday-Friday, business hours

  FLSA: Exempt

  Hybrid? Y

  CPF Level: D3

  Location: San Antonio

  Dept.: GenCure Manufacturing

  Business Unit: GenCure

  General Summary

  The successful Executive Director of Operations Support will support all critical manufacturing and technical functions and collaborate with partners and customers such as Operations and Process Development to achieve deliverables including process and analytics technology transfers with internal and external customers. This technical based support will extend to the following: cGMP operations, Process Development operations, production process scale, continuous improvement projects, process robustness enhancement, COGs reduction, lean manufacturing (six sigma), process scale up strategy, facility upgrade and enhancement, strategic business and operations process development, etc. The Executive Director will support formulating and administering company policies that can improve business operations and attain the strategic growth objectives of the organization. Reviews and analysis of financial statements and other performance data to measure the organization's productivity and goal achievement is also an expectation of the position.

  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 18 years old with a good driving record to meet organization driving standards.

  Major Duties and Responsibilities

  Essential Tasks

  Provide critical production process technical support for the manufacturing of cell therapy products

  Lead and manage process validation design, protocol preparation and review, IND/NDA/BLA filing reviews, while serving as SME (Subject Matter Expert) for CMC issues

  Interact regularly and collaboratively with external customers including Operations, Quality and Process Development, to resolve all cGMP issues effectively including discrepancy investigation and CAPAs, change control and management, product (DS and DP) release, tech transfer reports, key process development reports and continuous improvement project reports.

  Develops excellent working relationships with internal colleagues and leaders responsible for the delivery of projects and services to improve information exchange, project delivery, and understanding between groups.

  Design and direct production process monitoring and data trending and conduct trending analysis of cGMP batches.

  Identify and troubleshoot process deviations and suggest effective corrective and preventative actions and lead and author key investigation reports by closely working with Operations, Quality Assurance, and other relevant stake holders.

  Identify process improvement opportunities and implement process changes and improvements through quality systems by creating and managing a CI program (Continuous Improvement).

  Drive strong collaboration and communication across Operations, Quality and Process Sciences Tech Transfer teams to implement new projects.

  Lead new process internal tech transfers from Process Sciences to provide through review prior to introduction into Manufacturing.

  Support Sales and Project Management teams as the technical liaison and SME for Cell Therapy processes and operations.

  Support Sales team to enable business expansion of the portfolio (e.g. bid defenses and capability meetings). Support external tech transfers from clients to GenCure Operations and Process Development.

  Support the Operations team in maintain the cGMP manufacturing suites in a constant state of GMP readiness. Develop new manufacturing technologies with Process Development team.

  Introduce new manufacturing technologies to streamline operations, improve yields, and enhance quality (cGMP).

  Remain current on up ‐ and ‐ coming technologies, scientific breakthroughs, novel concepts and regulatory trends like PAT/QbD.

  Proactively pursue interactions with key experts in bioprocess development and biologics manufacturing including local and global academic experts.

  Routinely present and publish in international conferences on behalf of company to build strong positive reputation and perceptions while gathering industrial intelligence.

  Support the Operations and Process Development teams in the creation and review of Manufacturing and Process Development Batch records (both paper and electronic).

  Provide training for Sales, Operations, MSAT and Process Development staff on Cell Therapy processes and operations.

  May represent GenCure Business Unit at the governance level and contributes to the compilation of goals and business plan objectives for the strategic partnership.

  Serves as a customer's operations point of contact, and escalation support person for operational issues discussions. Communicates with sponsors regularly to identify potential problem areas and acts quickly to remove the risk resolve the issue.

  Design organization and recruit key talents globally to strengthen manpower capabilities and technical depth. Coach, mentor and develop key staff systematically with career path definition, career planning, training regimen

  to achieve high performance consistently.

  Performs other duties as assigned.

  Education

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

  Licenses and/or Certifications

  Valid United States Driver’s License

  Experience

  Requires fifteen or more years of job related experience. Requires ten or more years of Biological Sciences experience.

  Requires three or more years of management responsibility experience, with advanced leadership skills. Prefer Aseptic Processing and cGMP experience.

  In some cases an equivalency, consisting of a combination of appropriate education, training and or directly

  related experience, will be considered sufficient for an individual to meet the requirements of the role.

  Knowledge

  Must obtain a working knowledge of regulatory/quality requirements and perform within all Standard Operating Procedures (SOPs) and policies.

  Must maintain familiarity of regulatory/quality compliance, to include FDA, EU, ISO, GHM, cGMP, OSHA, etc.

  Must be able to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.

  Must have knowledge of the organization’s business operations to include core products, services, and customer targets.

  Must have a working knowledge in all aspects of technical procedures of a clinical laboratory.

  Must have a working knowledge of laboratory sciences and techniques.

  Must recognize and facilitate resolution of unusual results or difficulties encountered in all phases of laboratory work.

  Must be or become familiar with Just ‐ In ‐ Time (JIT), Kanban, and 6 ‐ Sigma.

  Must have excellent knowledge of the organization's industry in various lines of business, and its key/critical stakeholders.

  Must be able to interpret and explain policies and procedures.

  Must be able to demonstrate significant experience in the areas of aseptic operations (manufacturing and laboratory) including facility and equipment design, regulatory compliance, process development, and validations.

  Must be responsible for communicating the technical requirements for a project to vendors, contractors and consultants.

  Must acquire and maintain knowledge of the biotech/pharmaceutical industry including multiple therapeutic areas, with special emphasis on regenerative medicine.

  Skills

  Must have excellent critical thinking and problem ‐ solving skills.

  Must be capable of facilitating department project meetings and communicate effectively with internal customers throughout the organization.

  Must possess strong interpersonal skills including excellent negotiation and facilitation skills.

  Must be capable of effectively work with individuals at all position levels in the organization to identify, understand and communicate their business requirements.

  Must be capable of operating motor vehicles in all types of weather conditions.

  Must have experience using Microsoft Office applications including Word, Outlook, Visio, PowerPoint and Excel. Must have excellent written and oral communication skills.

  Must have excellent analytical skills to determine root cause and risk elements while considering alternative courses of action.

  Must be capable of creating, evaluating, and reporting technical and/or service related reports.

  Must be cost ‐ conscious, results ‐ oriented, and possess basic business skills.

  Abilities

  Must be a self ‐ starter and self ‐ directed worker.

  Must be able to anticipate future business needs and work closely with both business and technology vendors to implement solutions that meet business needs.

  Must be able to keep information confidential.

  Must be highly dependable and have the ability to make timely decisions.

  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 be results oriented, self ‐ starter, self ‐ motivated, a focus on goals, a sense of urgency and creative/ innovative/ forward thinking skills.

  Must have extensive experience managing multiple priorities; leading and implementing complex business and contractual issues; and serving as the principal liaison to business executives, internal and external.

  Must have the ability to lead training programs and cross ‐ functional teams.

  Must have the ability to meet time deadlines, connect and interrelate disparate ideas and thoughts, pay attention to detail, and work effectively with varying constituencies.

  Must have the ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.

  Must have the ability to think creatively and strategically while handling difficult and complex issues.

  Working Environment

  Works in a well ‐ lighted, air conditioned and heated office. May be exposed to electrical and chemical hazards and other conditions common to an office environment. May be required to work at any time of the day, evening or night during the week or weekend. Ability to use personal motor vehicle for company business required. Occupational Exposure Assignment ‐ Category II

  Physical Requirements

  Must be able to drive on behalf of the organization. Will sit, stand, walk, and bend during working hours. Requires ability to reach, lift and carry up to 20 lbs.

  Requires manual and finger dexterity and eye ‐ hand coordination.

  Requires normal or corrected vision and hearing corrected to a normal range.

  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 salary	• 100% Employer Paid Life Insurance
  • 401(k) with Employer Contribution	• 100% Employer Paid Long-term Disability Plan
  • Paid Time Off (PTO)	• 100% Employer Paid AD&D
  • Extended Illness Benefits (EIB)	• 100% Employer Paid Employee Assistance Program
  • Incentive Compensation Plan	• Group Health Medical Plan with prescription coverage
  • Shift Differentials	• Variety of Voluntary Supplemental Insurances
  • Paid Holidays	• Voluntary Dental Coverage
  • Educational Assistance Program	• Voluntary Vision

  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.

• About the company

  Connecting donors and patients, and supporting development of medical therapies.

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