We are currently seeking a highly motivated individual with strong hands-on experience for manufacturing operations to drive and achieve strategic short and long-term manufacturing objectives. Reporting to the Sr. Director Manufacturing, Engineering, & Quality, the successful candidate will be responsible for leading the manufacturing organization to achieve operational goals, meet manufacturing forecasting targets, quality measurements, and key performance indicators while adhering to corporate compliance standards and procedures. In addition, this individual will facilitate transfers of new products from R&D to manufacturing and identify and implement continuous improvements. This position will require problem solving and project management skills, as well as the ability to work with cross-functional teams. This position may require supervising production personnel or working with a contract manufacturer.
Mindera is a private San Diego-area company developing and commercializing next-generation medical technology to enable a new era of skin analytics at the molecular level. Using a proprietary dermal biomarker patch, Next-Generation Sequencing (NGS) and machine learning, Mindera technology generates clinically validated data to reduce healthcare system costs and improve patient outcomes. The platform has applicability in many chronic conditions.
Using Mindera’s proprietary FDA Registered Class I device, the Mindera platform allows for minimally invasive extraction of rich biomarker data from individual patient skin. Captured molecules are sent to the Mindera CLIA-certified lab for analysis and subsequent sequencing. Using machine learning, these baseline biomarkers can be correlated to clinical outcomes data from psoriasis patients who received specific biologic drugs, resulting in continuous evolving and improving predictive analyses for personalized drug responses. Systemwide, predicting biologic responses using Mind.Px can result in both improved psoriasis patient outcomes and billions of dollars of annual cost avoidance to the healthcare system.
Mindera won the prestigious 2021 MedTech Breakthrough Award – Best New Innovation, Dermatology and the Terra2 Skin Health Innovations Competition at the 2021 Winter Clinical Dermatology Conference. We are located in San Diego, CA. Find out more about us at www.minderadx.com.
- Plan, schedule, and execute manufacturing processes.
- Assist with planning and directing an efficient layout of equipment and flow of materials.
- Ensure manufacturing performance, volume, and quality goals are met by utilizing efficient methods.
- Manage day-to-day performance.
- Manage product in-house inventory.
- Assure project/department milestones and goals are achieved.
- Ensure compliance with health and safety regulations.
- Foster a professional working environment.
- Oversee core facility service providers such as building and equipment maintenance.
Strong expertise in the following fields is required:
- B.S. degree in Engineering or equivalent.
- 3+ years of Manufacturing Engineering in a Manufacturing and/or Operations environment in the biotech, medical device, or similarly regulated industry.
- Experience, training and/or certification in Manufacturing principles and/or Six Sigma methodologies. Experience with Statistical Process Control a plus.
- Working knowledge of quality system requirements (QSR), good manufacturing practices (GMP) and FDA regulations.
- Experience with a clean room environment including development and implementation of environmental procedures.
- Working knowledge of manufacturing systems.
- Hands-on with a strong sense of urgency, discipline, commitment, and organization.
Local candidates only (no relocation available).
Critical skills include:
- Experience with SolidWorks.
- Experience with project management software such as Smartsheet, MS Project, etc.
- Strong communication and organizational skills.
- Strong drive and motivation to work in a fast-paced, team environment.
- Attention to detail, ability to produce high quality work.
- Passion to contribute to the development of a new technology.
Competitive compensation package including stock options and benefits.
Mindera is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.
Apply by sending resume to firstname.lastname@example.org.