Manufacturing Director, Albumin

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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

POSITION SUMMARY:

The Albumin Manufacturing Director supports the start-up, qualification and commercialization of the new Albumin Purification and Aseptic Filling Plant.

Initially this person will manage the activities to transition the new plant from a start-up project through commissioning, qualification, validation and licensure. Once the facility is certified and operational and following approval to produce commercial material, he/she will be responsible for direct leadership over Manufacturing Operations, focusing on developing and improving the commercial requirements to meet supply chain demand and global business and customer needs, while ensuring compliance with applicable quality and regulatory requirements.

What you will be doing?

- Direct the effective planning, organization, development and execution of the Albumin Plant start up strategy and activities. Support design, construction, process development/selection and validation from the initial project phase through to the commercial manufacturing phase.
- Lead the cross functional project and operational teams to identify and prioritize continuous improvement opportunities from the initial pre-validation phase right through to commercial manufacture, to improve the quality, safety, reliability, RFT and productivity of the manufacturing and testing processes.
- Communicates regularly with employees, management and senior leadership about site performance, plans and initiatives.
- Oversee the strategic leadership of the Manufacturing Operations group, evaluating performance towards the achievement of production goals while maintaining worldwide regulatory compliance and minimizing errors.
- Serve as an internal resource in matters related to global supply planning, purchasing procedures, expense reduction initiatives, value analysis and contract negotiations where required
- Participate in regulatory and internal inspections/audits including providing written responses as applicable for areas of responsibility.
- Maintain current knowledge of regulatory and industry standards, trends and advancements through independent reading and training.
- Responsible for development of staff, including training and motivating in a manner that promotes the achievement of Company and department business goals and objectives.
- Address complaints and resolve employee related problems with the collaboration of Human Resources.
- Build organizational competency and succession plans. Involved in interviewing/selection process of hiring or promoting department personnel in line with company values and strategy.

Who we are looking for

- Qualifications

• Minimum of 8 years relevant experience in pharmaceutical / biologics operations including supply chain management, Manufacturing processes, and qualification and operation of new manufacturing facilities.

• Expertise in material and process flow knowledge (theory of constraints, lead time, transit times, etc.) for sterile production and distribution.

• Experience handling strategic sourcing, negotiation of complex business issues and risk assessments a plus.

• Strong knowledge of cGMPs, EU HPRA / US FDA regulations, and industry guidelines, as well as international regulatory guidelines for the production, labeling and distribution of human blood plasma derived medicine

• Excellent verbal and written communication. Must be able to read, write, and speak English.

• Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.

• Demonstrated leadership skills with ability to motivate, guide, train, coach and develop subordinates.

• Strong organizational, analytical, problem-solving, and spreadsheet skills, including cost modeling. Ability to analyze detail and perform structured decision-making on a daily basis.

• Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment.

• Ability to read and understand specification sheets, drawings, regulations (cGMP, QS, ISO).

• Willing to travel domestically and internationally as required
- Bachelor's degree in Chemistry, Chemical/Mechanical Engineering, Operations Management, Supply Chain Management, Business Administration, Material Science, or closely related scientific/ technical discipline.

Preferred:

- Experience in Human Serum Albumin Manufacturing Purification processes.
- Experience in Aseptic Fill Finish operations including sterile filtration, PUPSIT, Aseptic Behaviours and processing.
- Advanced degree in Chemistry, Chemical/Mechanical Engineering, Operations Management, Supply Chain Management, Business Administration, Material Science, or closely related scientific/ technical discipline desired
- Experience in leading a manufacturing operation through facility start up and product launch.

Our Benefits Include:

- Highly competitive salary
- Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
- Private Medical Insurance for the employee
- Ongoing opportunities for career development in a rapidly expanding work environment
- Succession planning and internal promotions
- Wellness activities - Social activities eg. Padel, Summer Events

We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you

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