About Us

We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions.  Our strength is giving others strength.

What You Will Achieve:

The Dermagraft Manufacturing Manager is responsible for overseeing all technical Dermagraft manufacturing operations to assure the reliable processing of the dermal equivalent by strict adherence to established SOP’s and protocols.  The manager will participate in the recruitment, hiring, and training of all technical staff, will conduct periodic performance reviews, proactively handle problematic job performance, and will effectively communicate to the Sr Manager/Director/Department head all problems or issues encountered in the clean rooms.  The Dermagraft Manufacturing Manager will be certified in all Dermagraft manufacturing.

How You Will Achieve It:

• Assist with the staffing requirements for the department including staffing projections, interviewing, and hiring.
• Assist in identification of areas of improvement in cost reduction/control, labor efficiencies, and scrap reduction.
• Participate in project management responsibilities, budget preparation, inventory/material interactions, and performance analysis.
• Maintain an effective Dermagraft technical training program and continuing education. Including In-services for manufacturing technicians.
• Responsible for preparing periodic Dermagraft manufacturing matrix reports for evaluation of scrap, yield, and in-process variables.
• Assure compliance with SOP’s, clean room protocols, and clean room policies in the Dermagraft clean room suites.
• Assure that all required certifications, calibrations, and validations within the Dermagraft manufacturing environment are performed according to established protocol.
• Provide technical and operational support and problem-solving capabilities as needed.
• Coordinate the implementation of corrective measures to remedy deficiencies cited in audits of the Dermagraft manufacturing environment.
• Responsible for ensuring all Dermagraft manufacturing documents are current and updated as required.
• Maintain technical certification in Dermagraft manufacturing, including cell-growth functions, including seeding cells, media changes, and harvesting of final product and packaging for commercial distribution as well as media preparation, autoclave preparation, and autoclaving.
• Ensure that operations and documentation conform to cGMP standards and that all SOPs and Batch Records are maintained to reflect current manufacturing methods.  Utilize technical writing skills to own and complete change controls and initiate deviation reports/CAPAs as required.  Ensure that training is maintained current, and that quality events and CAPA’s related to product quality and/or disposition are addressed and closed within the established timeframes.  

Requirements

What You Need to Achieve It:

• Bachelor’s degree in Biology or related science and/or 3 years experience as a production supervisor or Associate’s Degree in Biology or related science with minimum 4years of relevant experience. 
• Demonstrated expertise in aseptic processing, technical and analytical manufacturing techniques, current knowledge of GMP’s, excellent communication skills, and proven organizational and documentation skills. 
• Demonstrated leadership ability.  Quality Systems regulations (cGMP) knowledge and clean room experience preferred.
• Demonstrated expertise in aseptic processing, technical and analytical manufacturing techniques, current knowledge of GMP’s, excellent communication skills, and proven organizational and documentation skills.
• Interacts regularly with groups such as Engineering, Facilities, Calibration, Validation, and Quality to ensure accurate, well managed, and compliant operations for current and future processes and equipment.
• Experience with cGMP and clean room protocols strongly desired.
• Ability to work in the cleanroom for extended periods of time.
• Dexterity, coordination, and some lifting required.
• Microsoft excel and word computer experience.
• Dexterity, coordination and must be able to push 150 lbs. (on wheels), and lift 50lbs.
• Due to the nature of production work, overtime and weekend work as well as Holiday work is a requirement of employment and is variable based on company needs.

What can we offer you?

• 401k -- generous employer match with immediate vesting and financial planning resources
• Comprehensive Medical, Dental and Vision coverage options effective on day one of employment
• Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account
• Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options
• Paid maternity leave and parental leave for all new parents
• Adoption benefits
• Education Assistance Policy - $5,000 per year for all employees
• Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more
• Employee Assistance Program
• Generous paid time off including vacation, floating holidays, sick days, and company holidays
• Free parking including an electric charging station (Canton and La Jolla)
• Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint

The anticipated annualized base salary for this role is $110,000-$125,000 and reflects current market data for similarly-sized life science companies and internal equity.  Organogenesis is a multi-state employer, and this salary range may not reflect positions that work in other states. Base salary is part of our total rewards package which also includes the opportunity for merit-based increases, eligibility for our 401(k) plan with competitive company match, medical, dental, vision, education assistance, life and disability insurances and leaves provided in line with your work state and federal law.  This position is also eligible to participate in the company’s annual management bonus plan. Our time-off policy includes paid vacation days, paid company holidays, and paid sick time.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education, and other factors permitted by law.

We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, genetic information or any other characteristic protected by law.

We do not accept unsolicited agency resumes and we are not responsible for any fees related to unsolicited resumes.