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Manufacturing Manager (Associate Director)
Hercules CA | On-Site
Entry Date: 02 FEB 2024
Hercules CA | On-Site
Entry Date: 02 FEB 2024
X-Therma, a venture backed biotech company pioneers ground-breaking cold chain technology via a convergent biopreservation platform, to advance Regenerative Medicine and make available safe and on-demand organs, engineered tissues, and cell & gene therapies to patients in need. X-Therma collaborates with renowned research institutions such as Lawrence Berkeley National Laboratory and Johns Hopkins University and is supported with significant funding from the US Department of Defense, National Science Foundation, California Institute of Regenerative Medicine, etc.
X-Therma technology greatly improves cold-chain logistics and is an FDA Breakthrough Device to end the organ waiting list in a long-overlooked market. This is a paradigm shift that could make worldwide organ sharing possible and eliminate organ discard. Immediately, the technology could resolve current bottlenecks in Regenerative Medicine biomanufacturing and processing and allow “off-the-shelf" living medicines in this hyper-growth space.
Joining Team Excellence:
We have a bold vision to create something great that has never been done before: We are wary of what could go wrong, but obsessed with what can go right. We are mission-driven, intellectually honest and relentless learners, ambitious, courageous, and extraordinarily persistent. “Giving up” does not exist in our vocabulary. We respect and support each other to get better every day and make the world a better place. We are in the San Francisco East Bay in Hercules, not only known for its beautiful scenery and comfortable weather all year round, but also you can truly embrace the breath of innovation and dream building spirit of San Francisco’s Biobay.
To strengthen our growing team in Richmond, we are looking for an Senior Manufacturing Manager (Associate Director). This important role will take ownership for all manufacturing and overall facility operations in a broad perspective from facility planning and maintenance, process deployment and communications, manufacturing compliance, and overall excellence across organizational processes. Works closely with Quality Assurance to ensure operational compliance. Important for this role is working knowledge and appreciation of medical device and chemical research, quality assurance in manufacturing and laboratory environments.
What’s in it for you?
You will have a great opportunity to contribute to groundbreaking, life-saving products. You will be part of a team producing our novel life-saving molecules and solutions. This role demands a highly goal-driven approach and the ability to focus on time-sensitive objectives within the most urgent priorities.
What you will do:
Production:
- Oversees the manufacture of products, ensuring production, performance, and quality standards are consistently met.
- Reviews production reports to ensure safety, quality, financial, and delivery goals and standards are met.
- Strong knowledge in aseptic fill and finish products, Annex I, medical device manufacturing.
Infrastructure Management:
- Oversee the design and maintenance of laboratories.
- Ensure facilities comply with industry standards, safety regulations, and Good Manufacturing Practices (GMP).
Equipment Optimization:
- Implement strategies for the efficient use and maintenance of manufacturing equipment and technology.
- Collaborate with engineering teams to introduce new technologies that improve manufacturing capabilities.
Regulatory Compliance:
- Experienced directly in regulatory filing for cGMP, FDA.
- Ensure labs and facilities adhere to relevant regulatory standards, including cGMP, FDA regulations, and other industry requirements.
- Collaborate with regulatory affairs to address compliance issues and implement necessary changes.
- Ensures a healthy and safe working environment, and compliance with federal and state regulations, through collaboration with environmental, health, and safety staff.
Strategic Leadership:
- Develop and execute manufacturing strategies specific to labs and facilities, aligning with overall company goals.
- Drive initiatives to enhance operational efficiency and resource utilization in laboratory and facility settings.
Team Leadership:
- Lead a cross-functional team including facility managers, laboratory technicians, and support staff.
- Foster a collaborative and innovative culture to drive excellence in labs and facility operations.
Cross-Functional Collaboration:
- Work closely with X-Therma Sales teams to ensure production is deliver on time to meet the company business goals.
- Works with chief financial officer to develop manufacturing budget.
- Identifies and shares training opportunities for staff to build and improve skills.
- Assists chief operating officer with long-range operating goals, expansion efforts, and implementation of new and advanced technology.
- Delivers progress and production reports to executive team members as requested.
- Performs other related duties as assigned.
Qualification:
- Bachelor's or advanced degree in Engineering, Chemistry, or a related field.
- 8+ years of progressive experience in medical device or biopharmaceutical manufacturing, with a minimum of 5 years in a leadership role with a focus on labs and facilities.
- Relevant certifications such as Six Sigma, Certified Pharmaceutical GMP Professional (CPGP) or equivalent.
- Strong knowledge of laboratory operations, facility management, and manufacturing processes.
- Thrive in an early-stage environment with a proactive attitude; no task is too big or too small.
- A strong work ethic to deliver results within timelines.
- Strong analytical and problem-solving skills, organization and people skills and attention to details.
Physical Requirements:
- Prolonged periods sitting at a desk and working on a computer.
- Must be able to gown and assist work in clean room.
- Must be able to lift up to 50 pounds at times.
- Must be able to quickly traverse manufacturing areas.
- Must be able to stand, bend, crawl, stretch, lay, and squat in order to maintain equipment.
- Must be able to work in an office setting and observe laboratory settings without prohibitive limitations.
Other Skills and Abilities:
- Intermediate skills with Microsoft Office Suite, Outlook, intranet/internet networking, and security.
- Working knowledge of facility security systems such as badge readers and cameras.
Exceptional candidates will have:
- Knowledge and experience in cGMP, preferably FDA and ISO 13485 requirements.
- Experience managing operations in both large and small organizations.
- Deep personal drive to improve organ transplantation and/or regenerative medicine.
Our package includes:
- Competitive base salary.
- Senior manager $130,000-$150,000.
- Associate Director $160,000 - $180,000.
- Health, vision, and dental benefits, with high family coverage.
- 401(k) savings plan.
- Employee Stock Option Plan.
- 5-Day marriage leave policy.
- And more!
X-Therma is an Equal Opportunity Employer. X-Therma does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
