Posted on Tuesday, September 19, 2023
Biofidelity is a revolutionary genomic technology company dedicated to unleashing the potential of genomics to transform human health and the world we live in. Our adaptive platform technology removes the noise from genomic data, providing only the information needed to make decision making less complex, faster, and more accurate.
At Biofidelity we are proud to have built a culture of humanity, openness and high expectations. We work towards well-defined goals, with a strong belief that we can make genomics globally accessible. Our people are keen to take responsibility for their work and share both their successes and challenges.
Alongside a competitive salary and opportunities for career development, we offer a comprehensive benefits package including private medical & dental care, bonus, share option scheme, pension, income protection and life insurance, cycle to work scheme, season ticket loan, 26 days per year holiday allowance and free physical training sessions.
Biofidelity is creating a dedicated Manufacturing team responsible for the supply and scaling of its product portfolio. The Production Manager will be responsible for overseeing the production of molecular diagnostics products from raw material procurement to final product distribution. This role requires a combination of technical expertise, leadership skills, and a strong commitment to quality assurance and regulatory compliance. The Production Manager will collaborate with cross-functional teams to ensure that production schedules are met, and products are manufactured to the highest standards. This role reports to the Executive Director of Operations.
● Production Planning and Scheduling:
-Develop and maintain production schedules to ensure timely delivery of products.
-Monitor production progress and adjust schedules as needed to meet demand.
● Resource Management:
-Manage a team of, production scientists, and technicians, including hiring, training, and performance evaluations.
-Identifies and manages annual departmental capital, headcount, and expense budgeting requirements
-Authorises operational expenditures and maintains budget integrity and financial performance
-Generate proposals for capital equipment.
● Quality Assurance:
-Implement and maintain quality control processes and procedures to ensure the highest product quality.
-Collaborate with Quality Assurance and Regulatory Affairs teams to ensure compliance with relevant regulations (ISO 13485:2016).
-Ensure effective prioritisation, investigation, and resolution of findings impacting operation identified through audits, non-conformances, corrective actions, and customer complaint escalations.
● Inventory Management:
-Oversee inventory levels of raw materials, reagents, and finished products.
-Implement inventory control systems to minimize waste and stockouts.
● Equipment Management:
-Ensure validation requirements and calibration/maintenance schedules are maintained for production equipment and tools
● New Product Introduction
- Deliver design transfer requirements for new product introductions and product changes.
● Process Improvement:
-Continuously evaluate production processes for efficiency, quality, safety, scalability, and cost improvements.
-Identify areas for improvement and implement Lean manufacturing principles where applicable.
-Plan and implement business process optimisations
● Supplier and Vendor Relationships:
-Manage relationships with suppliers and vendors to ensure a reliable supply chain including contract manufacturers
-Negotiate contracts and pricing agreements to optimise costs.
● Health and Safety Compliance:
-Ensure a safe working environment for all employees by enforcing safety protocols and regulations.
-Investigate and report any accidents or incidents promptly.
- Ensure operational adherence to hazardous waste disposal.
● Documentation and Reporting:
-Maintain accurate production records, including batch records and manufacturing documentation.
-Generate regular reports on production performance and key performance indicators (KPIs).
Knowledge, Skills and Abilities:
● Demonstrated experience working cross-functionally and collaboratively across different teams (including Technology development, Product development, Quality, Clinical laboratory)
● Proficiency in a variety of molecular biology techniques and principles
● Knowledge in clean formulation and molecular grade processing required.
● Knowledge in production automation systems preferred.
● Applied knowledge of Six Sigma and Lean Manufacturing principles preferred.
● Mathematics and statistics aptitude preferred.
● Proficiency in Product Life Cycle Management and change control preferred.
● Working knowledge of cost accounting/manufacturing finance preferred
● Ability to follow written procedures with minimal direction.
● Strong communication and interpersonal skills with ability to relate to colleagues and customers at all levels.
● Ability to manage multiple tasks to deadlines, think on feet to solve problems and maintain a high level of accuracy, even in a changeable work environment.
● Proficiency in project management software and Microsoft Office suite.
● Ability to work in a fast-paced, dynamic environment.
Requisite Education and Experience / Minimum Qualifications:
● Bachelor's degree in a relevant scientific or engineering field; advanced degree preferred.
● Minimum of 5 years of experience in molecular diagnostics or biotechnology production, with at least 2 years in a supervisory or management role.
● Strong knowledge of molecular biology techniques and diagnostic assays.
● Previous experience of working under ISO 13485