You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.
Company Information
Our client is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing.
Job Summary
Reporting to the Manufacturing Director, the Manufacturing Manager will play a pivotal role in establishing the Manufacturing Department by supporting operational readiness and leading the manufacturing team to consistently deliver on specific Key Performance Indicators (KPIs). The Manufacturing Manager will work closely with the MSAT (Manufacturing Science & Technology) teams to ensure the effective and efficient tech transfer of products and processes to the facility.
Key Responsibilities
- Member of the Manufacturing leadership team.
- Support the execution of the overall Manufacturing strategy aligned with the facility’s strategic business plans and global Manufacturing strategy.
- Lead a team of Supervisors and Manufacturing Bioprocessing Associates to execute routine manufacturing activities of therapeutic proteins in a mammalian cell culture facility.
- Manage daily downstream manufacturing activities and ensure production timelines are met.
- Collaborate with MSAT and engineering teams on technical transfer, process validation, etc.
- Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections.
- Provides working knowledge and technical leadership in Downstream operations.
- Schedules and/or delivers training to manufacturing personnel to ensure staff can perform manufacturing operations safely and compliantly.
- Motivate, retain, develop existing group members and recruit new staff to build a strong Downstream manufacturing team.
- Contribute to continual improvement of all manufacturing documentation (SOP’s, MBR’s, OJT’s) to ensure they are current, accurate, and clear.
- Communicate operational status regularly to senior management, as required, at the appropriate level of detail.
- Assist the Manufacturing Director to coordinate the work between the Downstream groups and other functional groups to meet the production objectives and timelines.
- Perform all duties in accordance with GMP requirements, SOPs, and controlled documents.
- Will be flexible to take on additional tasks and responsibilities at the discretion of the Manufacturing Director.
- Will act as a role model for the Manufacturing function and also the wider organisation in adherence to corporate core values and company culture.
Qualifications
- Comprehensive knowledge and experience of relevant cGMP, safety and environmental regulations within the biopharmaceutical industry.
- Ideally, experienced in establishing a Manufacturing department and building a team of similar size and scale.
- 10+ years in biopharmaceutical manufacturing with extensive experience in Downstream processing.
- Experience in the large-scale chromatography, ultrafiltration/diafiltration, viral inactivation, filtration, etc.
- Experience in dealing with FDA, and/or EMA, and have a solid understanding of quality system in terms of deviation, investigation, CAPA and change control.
- Experience in working with cross-functional teams.
- Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the development, technical transfer and process validation.
- Must be quality-focused with knowledge and understanding of cGMP quality systems and how they apply to manufacturing operations.
Experience
- 10+ years in biopharmaceutical manufacturing.
Skills
- Technical skills relevant to downstream processing operations.
- Strong leadership abilities and the ability to adapt to a dynamic manufacturing environment.
- Excellent verbal and written communication and presentation skills.
- Strong interpersonal skills to work effectively with all levels of staff.
- Ability to work independently and proactively.
- Results-oriented, with the ability to manage multiple priorities in a short period of time.
- Excellent organizational and planning skills, strong attention to detail.
Education
- Certificate, Diploma, Degree in Science, Engineering or related field, or equivalent experience in the biopharmaceutical industry is essential.
- BSc, MSc, or PhD in Chemical Engineering, Bioscience, or Biotechnology is advantageous.
Additional Requirements
- Must be willing to travel as required internationally to fulfill the responsibilities of the position.
Medix Overview:
With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we’re dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.
