Winning the race to bring new healthcare products safely to a waiting world drives Rapid Micro Biosystems (RMB) to combine today’s innovative technologies as never before. Your career at RMB puts you at the center of diverse global teams that span robotics, AI, Machine Learning, imaging, microbiology, and more, re-shaping how urgently needed pharmaceuticals are made, tested, and released for decades to come. The sky’s the limit.
Careers at RMB are fast-moving, with the high growth you’d expect from a world leader in microbiology automation. Advancement at RMB affords an opportunity to achieve your personal goals and develop your passions, in an inclusive environment where every employee has the resources and opportunities to hone their skills. You’ll do more, learn more, and have the ability to make a profound impact on our business.
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POSITION DESCRIPTION
The Director of Industry Affairs will help Rapid Micro Biosystems (“RMB”) become the leader in biopharma quality control automation by advocating for and nurturing our relationships with customers, trade groups, regulatory agencies, and other important industry stakeholders. You will help coordinate activities that support our industry and regulatory strategies, including providing support and advice for internal and external customers in line with our strategy, preparing information for use with external audiences, defining our approach to key industry relationships, and providing important industry input back to internal stakeholders. In this role, you will interact with RMB’s leadership team, including the CEO, SVP of Sales, and others.
ROLES AND RESPONSIBILITIES:
Industry Relationships:
- Drive and maintain our customer advisory board strategy and approach.
- Lead and coordinate our participation in important industry events such as conferences and speaking engagements.
- Represent the company in industry trade association and/or consortium working groups.
Regulatory Environment:
- Serve as the liaison to regulatory agencies.
- Proactively evaluate, interpret, and communicate relevant global regulations, guidelines and evolving regulatory trends which impact company products and services.
- Provide consultative and training support to internal customers related to regulatory strategy.
- Find opportunities to strengthen the efficiency and effectiveness of regional and global regulatory affairs activities.
- Participate and/or lead projects to improve regulatory information sharing across the company.
Commercial Support:
- Work closely with the commercial team to provide scientific, technical, and regulatory support on sales calls, partnering meetings and present technical capabilities in sales meetings, conferences, seminars, and roadshows.
- Support and collaborate with Sales and Customer Support as a regulatory and technical point of contact.
- Support the development and commercialization of new product offerings from a regulatory and industry perspective.
- Support Marketing in development of technical content such as whitepapers and presentations
- Track 483 warning letters for possible sales opportunities.
EXPERIENCE AND QUALIFICATIONS
- Education: B.S. in Engineering, Biochemistry, Biology or related field plus relevant working experience (i.e., B.S. with 10+ years, Masters with 8+ years; Ph.D. with 5+years’ experience preferred)
- Must have experience in the Pharmaceutical Industry or equivalent life science discipline.
- Experience in biopharmaceutical industry, bioprocess development and/or manufacturing, or other science-based industries.
- Past experience working with or for the FDA or EMA preferred.
- Excellent customer facing track-record.
- Equivalent combinations of education, training, and relevant work experience may be considered.
- In-depth knowledge of pharmaceutical development, validation, manufacturing, and outsourcing including Good Manufacturing Practices.
- In-depth knowledge of functional areas, ability to translate from business strategy and company goals.
- Demonstrated decision making capabilities, and success as agent of change.
- Excellent interpersonal and communication skills, as well as the ability to motivate and lead.
- Demonstrated entrepreneurial / problem-solving ethic – resourceful, solutions-oriented, and inclined to attack problems with a can-do attitude.
- Outstanding communication skills, both written and oral, and the self-confidence to use these skills to convince others to buy into proposals and plans.
- Good organizational skills – proficient at structuring and driving projects from start to finish, from scoping to execution; capable of multi-tasking in a fast-paced environment under tight deadlines.
- Strong teamwork skills – ability to work in a cross-functional, non-hierarchical position and interact with individuals at all organizational levels.
ABOUT RAPID MICRO BIOSYSTEMS:
Rapid Micro Biosystems creates, sells, validates, and services innovative products for fast, accurate, and efficient detection of microbial contamination in the manufacture of pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products.
The company’s Growth Direct™—the first and only growth-based system to automate rapid compendial QC Micro testing—ensures data integrity, compliance, and operational efficiencies driven by rapid methods and automation.
Rapid Micro Biosystems is dedicated to providing groundbreaking technology and products to support companies in their journey to achieve greater reliability, efficiency, and better predictability, ultimately providing higher quality products for improved patient outcomes.
Rapid Micro Biosystems is headquartered in Lexington, Massachusetts. Our research & development, and manufacturing operations are located in Lowell, Massachusetts. Additionally, we maintain field offices in Freising, Germany; Switzerland, and Singapore.
Equal Opportunity:
Rapid Micro Biosystems is committed to the principle of equal employment opportunity. Applicants for employment and employees are reviewed on their individual qualifications for a position. Under no circumstances will Rapid Micro Biosystems discriminate against qualified persons on the basis of race, color, religious creed, retaliation, national origin, ancestry, sexual orientation, gender identity, disability, mental illness, genetics, choice of health insurance, marital status, age, veteran status, or any other basis prohibited under applicable law.