Sr Manager, Manufacturing Technical Operations

Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals.

From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support.

In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies.

We are a family-owned company with approximately 1100 employees from 25 nationalities. What unites us at Rentschler Biopharma, is the passion for what we do.

We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals.

Thus, we provide an important contribution to the global availability of essential therapies. Going forward, we are expanding our team to ensure our long-term sustainable growth.

Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together!

Duties and Responsibilities

• Serve as SME in managing the deviation, CAPA, and MOC lifecycle
• Author, revise and approve SOP’s, batch records, deviations and other documentation as required to ensure compliance
• Maintain metrics such as KPI and effectively communicate to clients, senior leaders and cross functional teams
• Ensure compliance with all GMP guidelines, product documentation, specifications, SOPs, and FDA requirements as required
• Manage, support and mentor team of Operations Analysts and Technical Writer
• Support multiple project initiatives, including driving Business Excellence and Continuous Improvement initiatives
• Work collaboratively with other Manufacturing supervisors to align overlapping processes including shared work areas, management of consumables, deviations, and corrective actions
• Communicate Manufacturing process status with relevant critical data and details to manufacturing management, staff, and other internal departments
• Support Manufacturing department during internal and external audits

Qualifications

• Masters degree in a scientific discipline (Biology, Biochemistry, Molecular, Chemistry, or related science) with 5+ years of relevant experience in pharmaceutical / biotech manufacturing and 3+ years of leadership role
• Bachelors degree in a scientific discipline (Biology, Biochemistry, Molecular, Chemistry, or related science) with 8+ years of related experience in pharmaceutical / biotech manufacturing and 5+ years of leadership role
• Associates degree with 10+ years of related experience in pharmaceutical / biotech manufacturing and 7+ years of supervisor / manager leadership experience
• Previous biomanufacturing experience Excellent cGMP knowledge in upstream, downstream, regulatory, compliance and audits responses
• Demonstrated interpersonal and leadership skills with ability to interface well with other departments and lead the team effectively
• Strong understanding of cGMPs and other regulatory guidelines applicable to commercial and clinical pharmaceutical manufacturing
• Experience with MasterControl or other QMS systems
• Ability to manage multiple priorities in a fast-paced manufacturing setting.
• Strong written and oral communication preferred
• Possess problem solving & assessment skills
• Ability to to meet deadlines and drive for results
• Demonstrated ability to interact with all levels of personnel to analyze and solve problems related to Manufacturing, Quality, documentation, and personnel issues
• Ability to analyze data and information to determine paths for process improvement (Six Sigma and Operational Excellence) and potential root cause / corrective actions
• Ability to respond to detailed inquiries, and present information to groups with varying levels of scientific knowledge and to senior management
• Proficient in Microsoft Office Excel, WORD, Power BI, PowerPoint, Teams, Outlook

Preferred Qualifications

• Must have experience dealing with Client Relationships in CDMO environments as CPM or PM
• Proficient in Microsoft Office. Ability to maintain and track KPI using Excel is preferred
• Knowledge of Six Sigma, Root Cause Analysis tools preferred
• Excellent knowledge in Downstream or Upstream Operations, or both would be preferable

Working Conditions

Normal office working conditions : computer, phone, files, fax, copier

Physical Requirements

• PPE as required
• Lab conditions
• Be able to gown into clean room environment as required
30+ days ago