Manufacturing Manager

Location

San Antonio, TX | United States

Job description

Kelly Science and Clinical is supporting a San Antonio, TX based CDMO providing cGMP manufacturing, bioanalytical and process development services for protein modalities. They make small-volume programs a big priority and are searching for a skilled Manufacturing Manager to lead an expanding team.

Title: Manufacturing Manager

Location: San Antonio, TX

Salary: Commensurate with experience

SUMMARY

Reporting to the Director of Manufacturing, the Manufacturing Manager will provide leadership for the Biomanufacturing Operations group. This entails managing all day-to-day cleanroom operations, supervising manufacturing staff, maintaining manufacturing schedules, and supporting client programs. In addition, this person will be responsible for the technology transfer of projects/processes into manufacturing from Process Development, as well as the manufacture of all cGMP-compliant, clinical-grade biologic products.

The ideal candidate must have a strict attention to detail, high quality customer service skills and the ability to instill these qualities onto others on the team.

RESPONSIBILITIES

• Following FDA or appropriate global regulations and guidelines, this individual will lead all cGMP manufacturing activities including the training, scheduling, and supervision of Manufacturing staff.

• Provide leadership for technology transfer from Process Development or external client teams. Responsible for collaborating with PD group to modify existing “R&D” manufacturing processes and develop them for clinical-scale, cGMP-compliant manufacturing. This includes transfer of processes into the cleanroom environment, process troubleshooting and generation of all relevant cGMP documentation (Batch Records, Compounding Records, Operating Procedures).

• Collaborate with Facilities staff in developing and managing the calibration, preventative maintenance, and validation strategy as part of the Equipment Control Program. This includes the development and implementation of operation and maintenance protocols for equipment and the execution and documentation of equipment validations.

• Collaborate with facilities staff develop, manage, and maintain the cleanroom environment ensuring compliance with global regulatory agencies at the highest-level including specifications for temperature, relative humidity, differential pressures, and air classifications.

• Support Quality Assurance group by assisting in employee training, document control, validation support, calibration, and preventative maintenance support, change control, deviation reporting, CAPA, risk analysis, etc.

• Manage relationships with outside contractors including equipment vendors, calibration and service contracts and validation firms.

• Representative to outside customers and be able to respond to their questions independently and accurately.

KNOWLEDGE & SKILLS

• Outstanding interpersonal skills: ability to build strong relationships with cross-functional team members and lead through influence.

• Must maintain a working knowledge of phase-appropriate cGMPs as they apply to various phases of product clinical development.

• Must obtain a working knowledge of current global regulatory requirements and guidelines and perform within all Standard Operating Procedures (SOPs) and policies.

• Ability to take responsibility and “get the job done” in a high-energy, high-intensity, results-oriented environment.

• Excellent verbal and written communication skills; strong presentation skills as this role requires the ability to communicate and connect with all levels of the organization.

• Must possess good to excellent writing and PC skills with a knowledge base in Microsoft Word, Excel, Power Point, and Project.

EDUCATION & EXPERIENCE

• Requires a B.S. or M.S. Degree from an accredited college or university with major course work in a Scientific or Engineering discipline.

• Requires 10+ years (BS) or 6+ years (MS) of cleanroom operation and maintenance experience.

• 3 + years of manufacturing leadership with progressive responsibilities

• Requires a strong background in cGMP principles and Quality Management Systems.

• Experience working in a GMP manufacturing environment is required.

• Hand-on experience with both upstream and downstream biomanufacturing processes is essential.

• Knowledge of manufacturing processes in a mammalian or microbial system is highly desirable.

• Proven project leadership skills and experience in supervising small to medium size teams is essential.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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