Sr. Director/VP of Operations
- Description: Full Time, Exempt
- Department: Operations
- Reports To: SVP-Strategy, Development and Operations
- Location: San Diego, CA
- Requisition Number: 2018/08/01
Biomatrica’s mission is to contribute to the development of better diagnostics and therapies, with improved access for patients globally. Based in San Diego, Biomatrica is privately held. The company is founded on a compound library and intellectual property which it deploys to collect, protect and store biomaterials subject to degradation, including nucleic acids, proteins, and cells. The applications are broad and include diagnostics, biobanking, research, and industrial. The company recently introduced an innovative line of CE- IVD marked sample collection products for: (1) cell-free DNA and tumor cells in blood for prenatal testing and liquid biopsy, (2) DNA in saliva for medical and personal genomics, (3) RNA and DNA for gene expression testing.
Strong operations and business leader needed to lead a diverse team in support of consumable products for use in in-vitro diagnostics and life-sciences research. This position will directly manage production, engineering, facilities, supply chain, distribution logistics, customer and technical support functions in a rapidly growing organization. This role requires an intense focus on meeting customer (internal and external) expectations and delivering to financial commitments while fostering a culture of accountability, collaboration and continuous improvement.
Essential Duties and Responsibilities (additional duties may be assigned)
- Develop operations plan and procedures to ensure high standards of quality, safety, efficiency and schedule compliance.
- Formulate and recommend policies and programs for various functions under management.
- Assume personal accountability for the performance of the Operations team across multiple functions under management.
- Ensure Safety is the number one priority for all employees.
- Drive compliance to applicable Quality System Guidelines and Regulations in regulatory environments (CE, FDA, QMS, ISO 13485).
- Lead the transfer of new products from development into operations.
- Coordinate the hiring, training, coaching and annual performance reviews of team. Facilitate and mentor the development of team members and front line leaders to be exceptional players.
- Develop and align operations strategies to business objectives and align them to annual goals priorities.
- Develop and establish strong operating mechanisms to ensure business objectives are met.
- Establish and track key performance indicators that drive change and visibility to the team and leadership. Effectively utilize shared resources across teams on multiple projects.
- Develop and execute robust Risk Management practices across all facets of the value streams.
- Bachelor’s degree in related discipline and/or equivalent experience. Master’s Degree or MBA preferred.
- Minimum of 10 years in management roles in IVD manufacturing, engineering or commercial operations in a complex and regulated operating environment.
- Domain expertise in managing production and supply of FDA regulated and CE-marked in-vitro diagnostic products.
- Strong track-record in scaling operations, establishing supply contracts and managing relationships with external vendors, OEM suppliers, contractors and consultants for various functions under management.
- Strong experience in managing global logistics and customer service teams in a rapidly growing environment.
- Demonstrated experience with international distribution of regulated products in the life science and in-vitro diagnostics industry
- Experience in leading operations teams in medical devices or molecular diagnostics.
- Experience within a cGMP environment to manufacture products under FDA QSR.
- Demonstrated experience and knowledge in the Quality System Regulations, ISO, and FDA submissions.
- Excellent verbal and written communication and interpersonal skills.
- Ability to leverage diverse resources, respond quickly, understand the impact of changes and decisions, facilitate agreement, build collaborative relationships and focus on customer needs.
- Ability to work with individuals at all levels and within all functions to motivate strong results.
- Practical experience in continuous improvement leadership/methodologies to drive productivity.
- Ability to effectively use data in problem solving and to evaluate process changes and impacts.
- Ability to partner with and influence key stakeholders including Finance, R&D, Product Management and the Commercial team.
- Must be able to independently manage multiple complex projects concurrently while meeting target dates.
- Lean and/or Six-Sigma Experience is highly desirable.
- Strong project planning, leadership, negotiation, and presentation skills as well as an ability to contribute creative yet practical solutions to problems.
- Ability to multi-task and manage several projects in parallel, paying attention to detail.
- Ability to travel as required (10-20%)
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
If you are looking for a position with growth potential in an exciting industry, please forward your resume and cover letter to: email@example.com and note “Sr Director / VP Operations” in the subject line of your e-mail. Please send attachments in MS Word or PDF format only with “your name-resume” and “your name-cover letter” as the document name. Relocation reimbursement is not available for this position.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons.