Director of cGMP Manufacturing
7 days ago
Job Description
The Company
Scorpius BioManufacturing is a boutique biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein modalities. Our facility in San Antonio, Texas specializes in working with start-ups, emerging biotechs, and academic researchers. Scorpius was founded by a serial biotech entrepreneur determined to make small-volume programs a big priority.
Clients benefit from decades of expertise taking large molecule drugs to market and can rely on Scorpius to offer Quality, Speed, Flexibility, & Responsiveness.
Position SummaryReporting directly to the VP of Manufacturing Operations and Site Head, the
Director of cGMP Manufacturing
will be responsible for leading the Manufacturing teams for both Mammalian and Microbial production in a cGMP environment.
The Director of cGMP Manufacturing will work collaboratively in the Site Leadership team with all site operations including Operations, Quality, Process Sciences, and commercial to support client programs at Scorpius BioManufacturing in San Antonio, Texas.
The ideal candidate must have tenured leadership skills, experience in Commercial Manufacturing of Biologics and Regulatory Inspections.Key Responsibilities
Partner with QA, Operation and Commercial to support Client Programs
Adherence to Manufacturing schedules and timelines
Ensure proper staffing and training to support cGMP Manufacturing.
Support Technology Transfer from Process Development or External Clients.
Represent Scorpius Manufacturing to outside customers and be able to respond to their questions independently and accurately.
Collaborate with Process Sciences 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, Standard Operating Procedures, and Media/Buffer Formulation).
Oversight of all current Good Manufacturing Practice activities including systems, procedures and practices.Provide guidance in the timely resolution of investigations, deviations, change controls, CAPA and other manufacturing or regulatory issues that may arise.
Provide career guidance, direction, ensures training and supervision of departmental staff.Provide strategic input to executive management.
Manage relationships with outside contractors including equipment vendors, calibration and service contracts and validation firms.
Education & Experience
Experience with Mammalian and/or Microbial Manufacturing at clinical and commercial scale, both upstream and downstream.
M.S. or BS. in relevant scientific areas or equivalent with a minimum of 10 years of experience in cGMP manufacturing.
15 years of leadership experience with continued increases in responsibility
Excellent communication (oral and written), organization and leadership skills.
Excellent regulatory knowledge of cGMP, or other relevant skills especially establishing internal and external quality systems and processes.
Prior experience in dealing with FDA and other regulatory agency personnel and understanding of their
requirements/expectations.
Knowledge & Skills
Proficient with all Microsoft Office applications.
Be a self-motivated, customer-oriented person with abilities to inspire and lead others.
Excellent communication skills for all levels for both internal and external clients.
Work professionally with colleagues and be a team player; maintain flexibility with work projects.
Complete work in a timely, accurate and thorough manner.
Think and work both tactically and strategically to provide operational needs to Scorpius' business.
Ability to read, write and analyze complex documents and provide solutions to complex Quality issues.
Respond effectively to sensitive inquiries, to support staff and customer inquiries or complaints as well as communicate effectively both orally and in writing.
Physical Requirements and Working EnvironmentAttendance at the plant is considered an essential function.
Flexibility is required for working hours. Some weekend work may be needed and earlier or later start/finish times may also be required.
The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate.
This position may involve a combination of office and laboratory environments and automated equipment.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 the ability to adjust focus.
The employee must have manual dexterity and manual ability to effectively use computer terminals.#J-18808-Ljbffr
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