Biomanufacturing Operations Manager/Senior Manager

Location:
San Antonio, TX
Reports to:
VP, Manufacturing Sciences

The Company

Scorpion is a fast-growing CRO and CDMO located in the biotech and life sciences hub of San Antonio, Texas. We offer a range of services and analytical test methods to support pre-clinical studies for large molecule product development as well as biomanufacturing and we are looking for an experienced Biomanufacturing Operations Manager/Senior Manager to join our team

Position Summary

Reporting directly to the Vice President of Manufacturing Sciences, this role will provide leadership for the Scorpion Biological Services Biomanufacturing Operations group. This entails independently managing all day-to-day cleanroom operations including supervising Operations staff, scheduling manufacturing events, as well as management of the ongoing Environmental Control Program. In addition, this person will be responsible for the technology transfer of projects/processes into Operations from Process Development, as well as the manufacture of all cGMP-compliant, clinical-grade biologic products.

Strict attention to detail, high quality customer service skills and the ability to instill these qualities onto others on the team.

Key Responsibilities

  • Following FDA or appropriate global regulations and guidelines, this individual will lead all cGMP manufacturing activities including the training, scheduling and supervision of Operations staff.
  • Provide leadership for technology transfer from Scorpion’s Process Development (PD) group and/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 to 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.
  • Supervise staff in the execution of ongoing Environmental Control Program. This includes developing and implementing facility cleaning procedures and environmental monitoring (EM) procedures. Responsibilities include the compilation and analyses of EM data (total air particulates, air viable counts, viable counts from settling plates and viable counts from contact plates) and generation of written reports.
  • 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.
  • Represent the Scorpion Biological Services biomanufacturing capabilities to outside customers and be able to respond to their questions independently and accurately.

Education & Experience Requirements

  • Requires a BS or MS Degree from an accredited college or university with major course work in a Scientific or Engineering discipline.
  • Requires 15+ years (BS) or 10+ years (MS) of cleanroom operation and maintenance experience.
  • Requires a strong background with 10+ in cGMP principles and Quality Management Systems.
  • Experience working in a GMP manufacturing environment is essential.

Knowledge & Skills

  • Knowledge of both upstream and downstream biomanufacturing processes is essential.
  • Knowledge of manufacturing processes in both mammalian and microbial systems is highly desirable.
  • Analytical ability, both interpersonal and issue-related; good judgment and ethics; professional presence and demeanor.
  • 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.

WORKING HOURS & Physical Requirements

  • Full Time, 40 hours per week
  • Flexibility is required, some weekend work may be needed and earlier or later start, and finish times may also be required.
  • While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear.
  • The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 20 pounds.
  • Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.
  • The employee must have the manual dexterity and manual ability to effectively use computers.

Join Our Team

BACK TO INDEX