Job Title: Manager, Manufacturing Operations
Reports To: Director, Manufacturing Operations
At Blue Earth Diagnostics our mission is to transform the clinical management of patients by developing innovative molecular imaging technologies. Our team is made up of industry leaders in the field of radiopharmaceutical development and commercialization. Blue Earth Diagnostics is a dynamic start-up with an approved product already on the market in the USA and in Europe. Blue Earth Diagnostics is backed by Syncona, an investment company listed on the London Stock Exchange.
Reporting to the Director, Manufacturing Operations & Quality, the Manager, Manufacturing Operations will be responsible for overseeing the day-to-day operations of Blue Earth’s 3rd party Contract Manufacturing Organization (CMO) network in the United States. In addition, the Manager, Manufacturing Operations will play a key role in the expansion of the CMO network through the successful execution of Technology Transfers. The Manager, Manufacturing Operations will also be responsible for the management of upstream KPI and other ancillary supplies that support drug product manufacture.
The incumbent will be comfortable working in a small, start-up environment and will have a proven track record of successful 3rd party CMO, supply chain and project management.
Essential Duties and Responsibilities:
- Oversees daily batch production across Blue Earth’s CMO network:
- Quickly and effectively manages any synthesis and/or logistics issues as appropriate.
- Communicates supply disruptions to relevant stakeholders in the field.
- Follows-up on any quality-related issues that may impact future site performance.
- Analyzes product demand against individual manufacturing site capacity.
- Maintains and analyzes key performance metrics of relevant CMO’s.
- Participates in the management of development projects with 3rd party manufacturers and liaises with relevant stakeholders for implementation at the site level.
- In conjunction with the Director, Manufacturing Operations & Quality:
- Manages upstream production materials and re-supply to sites/depots.
- Forecasts the utilization of production consumables and provides recommendations on re-supply quantities and timing.
- Interfaces with CMO’s on deviations, investigations and corrective actions.
- Holds periodic meetings with CMO’s and Blue Earth personnel and maintains meeting documentation.
- Works effectively with other department leads (Sales, Marketing, and Analytics etc.) to evaluate any changes to supply/demand paradigms.
- Proactively identifies any potential risks in the supply chain and implements effective corrective action.
- Strong understanding of both Blue Earth’s and assigned CMO’s Quality Systems.
- May participate in quality and/or due diligence audits of CMO’s or other external suppliers.
- Performs other duties as assigned by management.
To perform the job successfully the individual should demonstrate the following competencies:
- Interpersonal Skills and Ethics – A natural focus on “team”, with a resourceful and collaborative approach to working. Treats people with respect; inspires and earns the trust of others; conducts all activities with integrity while observing all relevant laws, regulations, ethical standards and conventions.
- Oral and Written Communication – Actively listens and responds effectively to questions; leads effective meetings; able to effectively prepare and then communicate options and recommendations.
- Cost Consciousness and Organizational Support – Works within approved budget; conserves organizational resources and offers suggestions on how to accomplish individual and business goals more efficiently and effectively at lower costs. Observes policies and procedures; completes administrative tasks consistent with company policies and on time; supports organizational goals and values; contributes to evolving culture.
- Planning/Organizing and Dependability – Is highly organized; prioritizes and plans work activities; uses time efficiently; sets goals and objectives with realistic action plans; proactively checks self against objectives and modifies as needed.
- Initiative and Innovation- Undertakes self-development activities; seeks increased responsibilities; looks for and takes advantage of opportunities; asks for and offers help when needed. Displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work.
- Bachelor’s Degree in a Life Sciences discipline required.
- Minimum 5-years’ experience managing 3rd party CMO’s.
- Minimum 5-years’ experience in aseptic manufacture, preferably in a PET radiopharmaceuticals environment.
- Thorough understanding of cGMP’s is required – experience with production of Investigational Medicinal Product (IMP’s) is a plus.
- Familiar with all aspects of a quality system, oversight and risk management. Prior experience with 21CFR Parts 211 & 212 is strongly desired.
- Experience in consolidating and analyzing data; and producing appropriate reports that reflect key performance metrics of assigned CMO’s.
- Regular domestic travel is required (up to 30%) with occasional international travel.
- Prior experience working in a small or start-up environment is preferred.
- Demonstrated ability to develop self; build high performance teams and develop others.
- Qualified candidate must be legally authorized to be employed in the United States.
HOW TO APPLY:
To apply, please submit your CV and a covering letter with the title of this job in the subject line to firstname.lastname@example.org outlining:
- Why this role appeals to you.
- How your background and skills are suited to this role.
Blue Earth Diagnostics offers competitive compensation for high-caliber candidates.
Blue Earth Diagnostics, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, ethnic/national origin, military and/or Veteran status, age, disability, genetics, marital status, sexual orientation or medical condition in accordance with applicable federal, state and local laws.