Manufacturing Sciences & Technology Product Manager

Date:  Jan 19, 2023
Department:  Scientific Affairs
Job Type:  Direct Employee
Team:  Mktg, Market Access, Bus. Excellence & Med. Affair
Contract Type:  Permanent
Location: 

Cary, NC, US

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels. 
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities. 

Chiesi USA

Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp™ and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work. 
At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.

What we offer

Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees.   Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues.  Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that “Every one of us is different. Every one of us is Chiesi."

 

Purpose

This position contributes to the company success by aiding in Chiesi USA adopting a cost-effective business model as it relates to the CGMP production and QC of its products. Virtually all products sold in the USA are produced through 3rd party Contract Manufacturing Organizations. This position has the technical responsibility to ensure Chiesi’s products are produced and tested under fully FDA compliant systems and processes.

Main Responsibilities

Business and Commercial Product Support
•    Manage the manufacturing activities of Chiesi’s commercial portfolio, including non-sterile, biologic, and sterile products at Contract Manufacturing Organizations (CMOs) in collaboration with QA, Regulatory Affairs and Supply Chain.
•    Maintain commercial product portfolio in compliance with technical requirements from existing and new FDA regulations, in accordance with CGMP principles.
•    Serve as a Technical Subject Matter Expert for assigned products.
•    Responsible for Technical Robustness of Manufacturing Processes and Analytical Methods of commercialized products.
•    Provide technical support for post-approval product changes in collaboration with QA and RA.
•    Initiate and implement FDA new guidance regarding to product and process improvements/requirements and/or new technologies. 
•    Manage and lead Risk Management efforts related to manufacturing efforts, according to FDA and ICH requirements. 
•    Author, and/or review and approve Design of Experiments, protocols, reports, and technical documents in a precise and scientifically sound manner.
•    Review and provide feedback on all technical documents provided by the CMOs prior to implementation (studies, protocols, reports, risk assessments, statistical process controls, etc.). 
•    Provide project updates to internal and external stakeholders on a regular basis.
•    Obtain, review, and approve project quotations, proposals, and contracts from CMOs and contract Analytical laboratories in conjunction with Management.
•    Coordinate, provide direction, and monitor effectiveness of external consultants
•    Plan, manage, and monitor study experiments at CMOs or contract laboratories.
•    On-site monitoring of product manufacturing activities when required.
•    Conduct technical reviews and summaries for CMO based investigations, Change Controls, CAPAs, and Process improvements

Note: This is an individual contributor role with demonstrated independence and collaborative skills
Technical lead for Drug product and Drug Substance (API) transfers 
•    Establishing technical strategy and scope for tech transfers of drug substance and drug product manufacturing
•    Monitoring both Project and Technical Risks of the Tech Transfer
•    Providing routine updates and feedback to internal and external stakeholders.
•    Communicate program progress, risks, and mitigation strategies at key program milestones. 
•    Responsible for Review and approval of all technical documentation, including engineering batch records, technical studies, analytical testing and process validation protocols/reports, review of CMC filing documentations, and Final transfer documents.  
Business and QA support
•    Participate in supplier and PAI readiness audits when required
•    Act as CUSA Technical SME for various products and assets within the organization
•    Participate in Due-Diligence activities as requested.

Experience Required


•    Biologics and Aseptic processing experience. 6-8 years total experience. Post Graduate degrees in a scientific field are preferred, and can be counted towards total years’ experience.
•    In-plant experience in CGMP biologic and aseptic processing is mandatory. This experience can be demonstrated through operations, validation, process engineering, or MS&T experience.
•    Demonstrated experience in tech transfer of both analytical methods and manufacturing processes and equipment.
•    Knowledgeable of chemical, biochemical, and microbiological analytical method development, validation, and regulatory requirements is required.
•    Capable of working independently with minimal supervision, a proven self-starter, with a proactive approach to their work.
•    Demonstrated capability to work collaboratively within multiple teams, organizations, and cultures; capable of exercising influence without authority when necessary.
•    Experience in Technical Operations, Process Validations (Stages 1,2,3), Equipment Qualification, Change Control, CAPA, and process improvements.
•    Experience working in a virtual environment and managing contract manufacturing organizations (CMOs) relationships and work product.
•    Experience working with various government agencies including but not limited to the Federal Drug Administration (FDA), OIG, Health Canada.
•    Proficiency in reading, interpreting, and evaluating process and analytical related data. Fundamental understanding of statistics and process controls is required.
•    Strong technical writing skills, including technical protocols, reports, investigations, risk assessments, and technical justifications.
•    Understanding of US federal regulations and processes related to the development of drugs and post-approval changes.
•    Demonstrated proficiency in Written, Verbal, Oral, and Face-to-face communication to effectively present information to and influence decision making process for internal and external customers   
•    Ability to successfully manage and prioritize appropriately when multiple tasks and multifunctional resources are required.  Maintains a high attention to detail while responding to changing priorities and aggressive deadlines. 
•    Ability to work independently with minimal supervision. Takes initiative.
•    Maintains knowledge of industry trends and process requirements/technologies/FDA regulations. 
•    Proficient in MS Office (Word, Excel, MS Teams, Microsoft 365) and Adobe.
•    Project management skills are desirable including meeting facilitation, effectively setting agendas, minutes, actions and decisions.  Capable of reviewing and holding themselves and others accountable to established timelines.

Education

  • BS/BA in Chemistry, Chemical Engineering, Biomedical Engineering, Biological Sciences or equivalent scientific degree minimum. Graduate degree preferred.

Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business.  All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.

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