Manufacturing Manager
Wanting to contract with an individual experienced in setting up and managing the contract manufacturing of plastic, single-use,
sterile blood processing disposables for clinical use that will be regulated under the FDA 510K process for a Class II device.
Applicants must demonstrate successful experience bringing such products from the development stage to full production and sale
with aftermarket tracking and addressing of field problems. Applicants must show mastery of fulfilling all aspects of achieving ISO,
ASTM and IEC compliance.
The successful applicant must be hard working, highly self-motivated yet fit seamlessly in a team with the design
engineers and the regulatory personnel in managing this successful transition.
Compensation is negotiable but will include bonuses at milestones achieved.
Please send your resume and cover letter to
info@syngeninc.com
SynGen is an Equal Opportunity Employer (EOE). If you need assistance or an accommodation during the
application process because of a disability, it is available upon request.
Business Development Manager – Stem Cell
We are seeking a business development professional, experienced in medical devices, biotech and regenerative
medicine to leverage our expertise and product development. Our product platform technologies enable the research,
diagnostic, and clinical use of stem and progenitor cells. You will be responsible for growth through management
of our existing strategic relationships and growing pipeline of alliances. The successful candidate must have a
strong background with regenerative medicine and/or stem cell product organizations.
This position is responsible for identifying, researching, analyzing, and bringing to market new businesses and
products/services that maximizes our platform technologies. This individual will be actively engaged in the
establishment of strategic partnerships as appropriate. This position will report to the founders.
An appropriate science degree and a MBA would be preferred.
If you are interested in applying for this position, please submit your resume to
info@syngeninc.com
SynGen is an Equal Opportunity Employer (EOE). If you need assistance or an accommodation during the
application process because of a disability, it is available upon request.
Controller
This position requires a talented self-starting professional with broad skill sets. Main duties include ensuring a strong system of financial controls; financial reporting; annual audit; budgeting; financial oversight of our growing joint venture activities and financial modeling. Preference will be given to an operationally orientated individual who can support our supply chain and distribution networks. The successful candidate will have an accounting degree (CPA preferred) and/or MBA, appropriate work experience including familiarity with a rapidly expanding small business. This is an excellent professional growth opportunity for the right candidate.
If you are interested in applying for this position, please submit your resume to
info@syngeninc.com
SynGen is an Equal Opportunity Employer (EOE). If you need assistance or an accommodation during the
application process because of a disability, it is available upon request.
Director: Regulatory Affairs
The Director of Regulatory Affairs is responsible for obtaining FDA and CE mark clearance for our device products and managing a continuous quality improvement program that allows a reliable supply of the highest quality products in our field to our customers while remaining in strict compliance with all regulatory standards. Duties include internal audits and inspections; strategic guidance to executive personnel, operations, and R&D teams; ensuring compliance with applicable ISO, EN, MDD, Canadian, and FDA/QRS quality systems; supporting activities in labeling, manufacturing, marketing and clinical trials for regulatory compliance; leading in efforts for establishing post-market surveillance programs; performance of first article label inspections and compliance review; supporting international registration efforts by obtaining and supplying supporting documentation and guidance in the implementation of synchronized standards which include ISO, MEDDEV, STED, RoHS WEEE and others as applicable to our global objectives. College degree and work experience commensurate with stated job duties.
If you are interested in applying for this position, please submit your resume to
info@syngeninc.com
SynGen is an Equal Opportunity Employer (EOE). If you need assistance or an accommodation during the application process because of a disability, it is available upon request.
Our Chief Scientific Officer
We are seeking a seasoned scientific leader experienced in integrating life sciences, chemistry and biomedical engineering to lead a team that will develop and commercialize medical products for regenerative medicine. The successful candidate will integrate scientific affairs with regulatory, medical, marketing, finance, manufacturing, quality and senior management functions. The candidate should be experienced in budget control and personnel management. We are seeking a CSO capable of establishing a strong Scientific Advisory Board (SAB) and developing enduring relationships with thought leaders in academic and government positions. The candidate must have earned a MD. or Ph.D. in a Life Sciences discipline.
Our CSO must have a proven track record of identifying and resolving key technical issues in product development as well as recognizing and evaluating new product development opportunities. Our CSO must also have strong communication skills (technical writing and oral presentation) for technical, business and regulatory audiences. The candidate should be able to travel up to 25% of the time and to have their primary residence in the Sacramento area.
Specific Responsibilities:
- In consultation with the CEO, establishes the companyÕs strategic research and development roadmap and activities in support of the business plan.
- Leads the R&D department and life science laboratory operations.
- Leads the technology transfer from any licensees and to any licensors.
- Establishes the manufacturing process for all products including determination of release criteria and writing SOPs for use.
- Develops and manages pre-clinical studies.
- Builds partnerships and relationships with the scientific community and industry partners.
- Presents the company as the leading provider of Òenabling toolsÓ that provide clinically relevant cells for regenerative medicine and a preferred partner for leading institutions in the world.
- Ensures that the company has access to the most promising research programs in the field of regenerative medicine.
- Maintains a positive collaborative relationship with other functional heads in the company while representing the technical organization.
- Is the company safety officer.
- Assists in the financial management of the company by helping establish budgets and manage resources.
Qualifications:
- Life science Ph.D. or MD degree.
- Minimum 15 years of relevant industry experience in pharmaceutical or biotechnology industry, 5 or more years experience in blood, bone marrow, stem cells or cell biology research.
- Supervisory experience.
- Proven track record of successful relationships with opinion leaders and investigators.
Ability:
- Strong results driven personality.
- Managerial skills: train and mentor R&D team to help them optimize their personal development.
- High level of enthusiasm, energy and confidence.
- Excellent analytical, communication, organizational and presentation skills.
- Ability to demonstrate flexibility and integrity.
- Ability and willingness to work on a Òhands onÓ basis using personal expertise.
- Work precisely according to procedures, rules and regulations.
Languages:
- English, additional languages is a plus.
If you are interested in applying for this position, please submit your resume to
info@syngeninc.com
SynGen is an Equal Opportunity Employer (EOE). If you need assistance or an accommodation during the application process because of a disability, it is available upon request.
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