Please see my current opportunities below. All opportunities are for local (US based) candidates with valid work visa with all required industry experience. If you have an interest then please send an email (resume as an attachment) at wd under score darshana a&t hot mail or find me on Linkedin.
Senior Director/ VP of Regulatory Affairs – San Jose, CA
The position is independently responsible for development of global regulatory strategy and representation of Regulatory Affairs on R&D project teams & will be responsible for managing all Regulatory Affairs activities (nonclinical and clinical) for investigational drug-device combination products from preclinical candidate designation through product approval, including regulatory submissions. Responsible for knowledge of regulatory requirements of major regions (US, EU, Japan and China) and for covering multiple development projects.
Major Duties and Responsibilities
- Develop and execute regulatory strategies for earliest possible approvals for development programs.
- Provide expertise in translating local, regional, and international regulatory requirements into workable plans with cross-functional teams.
- Set strategy for submissions of product registration documents to health authorities worldwide. Interact with other line functions in the preparation, review, and completion of documents for regulatory submissions.
- Prepare submissions and regulatory filings of INDs, CTAs, BLAs, NDAs, MAA and other submission documents including meeting packages, briefing documents, responses, supplements etc.
- Experience in CMC regulatory compliance to ensure CMC practices are carried out in agreement with regulatory agencies requirements and expectations
- Review clinical trial documents including clinical protocols/reports, investigator brochures, nonclinical reports, protocols/test methods; review and approve clinical manufacturing plans and labeling, and authorize drug shipment to clinical sites.
- Interact with regulatory agencies on defined matters. Liaise with regulatory agency project manager in coordinating meetings, providing responses to agency questions/requests.
- Serve as Regulatory representative on project teams, manage regulatory timelines, and provide strategic input as applicable.
- Interface with international affiliates on regional regulatory strategy and implementation of plans.
- Effectively plan, organize, and conduct (or supervise) formal meetings with regulatory agencies. Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.
- Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines.
- Contribute to the development and maintenance the Regulatory Affairs working practices and procedures.
Education and/or Job Experience
- Bachelor’s or Master’s degree in a scientific discipline.
- 10-15 years’ experience in Regulatory Affairs in biotechnology & pharmaceutical industry.
- Thorough knowledge of the drug, device and combination product development process with demonstrated experience in developing global regulatory strategy and submissions.
- Experience in multiple phases of development in various therapeutic areas is desirable.
- Experience with biologics is a must.
- Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
- Ability to communicate and interact effectively across departments and on project team(s).
- Results driven and team-orientated, with the ability to influence outcomes.
- Ability to travel
PROJECT MANAGER – San Jose, CA
We are seeking an experienced Project Manager to lead the successful execution and launch of engineering projects in a fast-paced environment. The position has responsibility for daily management of complex projects and requires a high degree of coordination with a cross-functional team including Engineering, Manufacturing, Biology, Quality and Facilities.
- Oversee and drive multiple engineering projects of various size and complexity from initiation through validation and production release
- Responsible for developing realistic project schedules, along with resource planning, risk management and measurable metrics to meet the project goals
- Communicate progress to stakeholders including the executive leadership team and provide recommendations for mitigating risks or delays
- Coordinate interdependent tasks and deliverables with key stakeholders including R&D Engineering, Manufacturing & Process Engineering, Facilities, EH&S, and Quality Assurance
- Lead and manage team meetings by creating agendas, presentations, minutes and action items. Document team decisions and follow up on action items and deliverables
- Comply with company’s policies and guidelines regarding design control, validation activities and documentation
- BS degree in engineering or a related technical field
- 7-10 years of experience with managing engineering projects and use of standard project management methodology, tools and/or software packages
- The successful candidate will apply strong people and negotiation skills to plan, coordinate and execute all relevant activities in a phase- gate setting
- Excellent interpersonal skills with an ability to communicate to people at all levels of the organization
- Strong leadership skills, self-motivated and ability to influence others to achieve successful outcomes
- The position requires a high degree of adaptability, flexibility, creative decision-making, and technical problem-solving abilities
- Excellent verbal, written, presentation and interpersonal skills
- Must be able to handle multiple projects with exceptional organizational and time management skills
- Proven experience using Project Management tools to manage complex project timelines as well as fluency with Excel, Word, PowerPoint and Visio
- Proven track record with Medical Device, FDA regulations, ISO, cGMP and QMS standards
- In-depth understanding of verification & validation (IQ,OQ,PQ) as well as risk analysis (FMEA)
- PMP certification
- Experience with Visual Project Management
- Experience with turnkey, capital equipment
- Familiarity with sterilization process and aseptic manufacturing
Up to 10%
Quality Assurance Engineer – North San Jose, CA
There is immediate opportunity for Quality Engineer in well funded startup by a veteran leader with a world class team to support compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the Sr. Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for class II and class III medical devices and combination products. This position also ensures that the company complies with all applicable federal, industry, and company procedures, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.
Maintain and improve quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements; Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs; Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause; Lead the resolution of quality issues related to non-conformance reports and CAPAs; Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ); Provide QE support to production, purchasing and engineering; Support/lead test method validation activities; Conduct and support the development and validation of appropriate test methods for product and process performance; Develop and initiate sampling procedures and statistical process control methods; Support product line manufacturing and design stages by ensuring validation of manufacturing equipment and processes are conducted in accordance with the Validation Master Plan; Address systemic quality issues with suppliers or internal groups; Oversee calibration and preventive maintenance program; Assist in the review of lot history records and disposition of product (subassembly and finished goods); Work with engineering to develop adequate inspection criteria; Perform statistical analysis such as capability, gage R&R, and statistical process control; Evaluate product changes for qualification and validation requirements and assist in change implementations.
A minimum of 7 years quality assurance/engineering experience is required. Experience in a regulated industry (medical device), Experience with FDA Quality System Regulations, ISO Standards (ISO 13485 and ISO 14971), Experience with non-conformances, CAPA, and Risk Management, Experience in performing test method validation and Gage R&Rs, Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes) and BS in Engineering is required. CQE, CQA preferred
Quality Engineer – South San Jose, CA
Exciting bay area start-up on catheter development to focus on improved outcomes of arterial disease has an immediate opportunity for a manufacturing minded Quality Engineer.
Support QA/QC/QS functions and activities in a medical device manufacturing environment; Establish purchased materials RI acceptance criteria & perform RI; In-process/final device inspection; Technical Writing for Design History File documents etc, Regulatory & Quality System documents; Design, write & perform equipment qualifications & process validations; establish & maintain equipment calibration & maintenance; support team, contract manufacturers & suppliers with robust & statistically valid testing, sample size selection, monitoring & analysis requirements
5+ years medical device work experience (vascular catheter exp preferred), formal statistics training, Validation protocol design & report writing exp, exp to work in & maintain compliance of a certified QMS related to configuration control, document control & change control, enthusiasm for producing cool new products for catheter development. College education preferred.
Bioanalytical Lab Research Scientist – San Jose, CA
This is an exciting opportunity for a bioanalytical scientist to join world class team to work on drug-device projects, with the potential to dramatically change patient outcomes. Position, salary, and benefits are commensurate with experience, with possibility of option grants!!
Required: Background in medical device or pharma testing & regulatory development. Experience in preclinical and clinical research is a must. The candidate must have technical training in biochemistry and/or pharmaceutical sciences with experience using lyophilization, Karl Fischer titration, and HPLC. Experience with biochemical analysis such as spectrophotometric and fluorescence immunoassays, and LC-MS is a plus. Also required, degree in biochem or pharma sciences w. 2+ years experience, extensive exp in various analytical techniques & bioanalytical assays.
Responsibilities: Lead projects on biologic formulation, drug product process development; Executes experiments based on protocols and implement; Develop & maintain documentation, test methods, study protocols, SOPs, worksheets, forms, and reports; Design and manage data from complex experiments including preliminary statistical analysis; literature searches; Maintain lab & assay operations notebook, equipment, supplies, computer files; Support regulatory efforts.
Bioanalytical Lab Scientist – San Jose, CA
There is an exciting opportunity for a bioanalytical scientist to join a team working on drug-device combinations projects w/ potential to change patient outcomes. Attractive benefits package with competitive salary is offered and option grants makes this exciting opportunity. Perform literature search, routine data management, tabulate & graph results, support regulatory efforts & manage lab supplies, safety, equipment.
Responsibilities: Perform bioanalytical assays for the quantification of the analytes in in-vitro, preclinical and clinical samples; Participate in the development of in vitro/in vivo models by performing a variety of microplate assays independently with minimal supervision; Configure, program and troubleshoot laboratory automated platforms; Optimize existing automated processes to improve efficiency, throughput, robustness and quality. Perform literature search, routine data management, tabulate & graph results, support regulatory efforts & manage lab supplies, safety, equipment.
Required: Background in medical device or pharma & exp in preclinical and clinical research is a must. Also required, background in biochemical analysis such as spectrophotometric, fluorescence immuno assays, HPLC, CE, LC-MS. exp w/ microplate assays is must and experience with Luminex MapX technology is a plus. BS + 3 yrs work exp or MS + 1 yr exp and exp in writing reports & SOPs, knowledge of statistical software like Excel, GraphPad, Prism & Softmax Pro and hands-on exp in automation & liquid handling in a bioanalytical lab is required.
Senior scientist role requires 5+ years work experience.
Senior Scientist/ Dir – S. San Francisco, CA
Senior Scientist/ Director/ VP (commensurate with experience)
An early stage biotechnology startup with patented technology for engineering mammalian cells to vastly increase productivity for therapeutic proteins & disrupt biologics manufacturing, has two exciting openings. (The company has backing from J&J).
Job Functions: The work will involve vector design & preparation, transfection, cell culture, cloning & screening, flow cytometry & other related molecular and cellular biology techniques. Collaboration with co-workers & pharmaceutical company customers is essential for this position.
Requirements: Candidate is required to have Ph.D. plus multiple years of experience with cell line creation, mammalian cell culture expertise, know regulatory landscape related to creating & testing cells for GMP manufacturing; exp. with molecular biology techniques for creating vectors & transfecting cells: exp with protein assays, with a goal to further develop the technology toward full commercialization. Experience with flow cytometry, cell banking, transposase transfection methods a huge plus.
There is immediate opportunity for Manufacturing Engineer in San Jose, CA, in a well funded startup by a veteran leader with a world class team.
Senior & Junior Mechanical Engineers – San Jose, CA
A bay area company with world class team, has an exciting opening for Senior & Junior Mechanical Engineers to design, develop & validate semi or fully automated equipment used for scale-up of high volume, disposable devices.
Responsibilities: Develop concepts & ideas for improving tooling, create new tooling, evaluate current manufacturing processes & workflows, take ownership of design, create User Requirements Specs, conduct concept reviews, show proof of concept through prototyping, support test data, coordinate with stakeholders for V&V, launch & documentation, created 3D models, engineering drawings & bills of materials, participate in design FMEA, plan to mitigate risks, and work with outside vendors, machine shops, contract manufacturers.
Requirements: BS in ME plus 3 to 13 years of medical device industry experience with complex mechanical/ electromechanical design, extensive experience with precision mechanisms pneumatics, servo systems, tooling/ fixtures, motors, belts/ pulleys, gears, actuators, sensors and experience creating engineering drawings, BOMs, products specs is required. Also required knowledge of material properties, heat treatment & surface finish, understanding of DFM & lean manufacturing, and track record with medical device manufacturing methods, RDA reqgulations, ISO, cGMP & QMS standards is required. MS in ME, experience with plastic injection molding, knowledge of DOE, SPC, JMP/ Minitab, experience with metal stamping, laser cutting, chemical etching, familiarity with sterilization process & aseptic environment and PLC programming would be a big plus.
Mechanical Engineer R&D – San Jose, CA
Senior Mechanical Engineer is responsible for evaluating and improving the current drug delivery system by testing and optimizing components or sub-assemblies as needed. He/she will work with quality & regulatory to develop complete documentation for the device.
Responsibilities: Evaluate current design & identify opportunities for improvement, show proof of concept through prototyping and supporting test data, document internal design control SOPs, lead V&V activities, create 3D models, engineering drawings & bill of materials, create work instructions & manufacturing SOP’s, work with quality, and outside vendors, machine shops, contract manufacturers and comply with company’s policies & guidelines regarding quality & regulatory.
Qualifications: BS in ME + 5 years hands’on experience in medical device design environment, experience with creating engineering drawings, BOMs, product specs, experience with implementing product into manufacturing, knowledge of FDA regulations & ISO, cGMP, QMS standards, understanding of DFM & lean manufacturing, experience with machine shop tools & SolidWorks. Master’s degree in ME or BME and/or experience with plastic injection molding, a huge plus.
Senior Catheter Design Engineer – S. San Jose, CA
There is an immediate opportunity for a Senior Catheter Design Engineer with 15 to 20 years experience in catheter design engineering in a stealth mode company that is less than 2 years away from getting its first two devices 510 K approved and launched. The company is led by a visionary leader and has highly experienced engineering and management team. This a hug opportunity to participate at grounds level in what is a truly exciting and game changing technology that is poised to change the quality of care of cardiac patients, with a potential to save millions of healthcare dollars, on regular basis. Experience is IVUS engineering a huge plus.
Manufacturing/ Test/ Quality Engineer – S. San Jose, CA
A stealth mode cardiovascular company with experienced engineering team, led by a serial entrepreneur, has an immediate opening for Manufaturing/ Test/ Quality Engineer. This requires 10 plus years experience in the filed of catheter engineering.
Catheter Design Mechanical Engineer – S. San Jose, CA
A stealth mode cardiovascular company, led by a serial entrepreneur with prior experience in building a company, has an immediate opening for Catheter Design Mechanical Engineer. The position requires 5 to 10 years of experience in catheter engineering, a can do, problem solving attitude, excellent conflict resolution skills and an ability to handle uncertainty.
Program/ Project Manager – S. San Jose, CA
A stealth mode cardiovascular company with world class engineering team, led by a veteran leader with prior experience in building a company, has an opening for Program Manger with experience of working in catheter engineering industry and a demonstrated history of managing projects all the way from conceptualization, team building, cost estimation, implementation, regulatory 510 (K) approval, and production support to launch. Experience in catheter engineering and leading 510K approval program is absolutely essential.
Supply Chain Management/ Strategy Leader – S. San Jose, CA
A stealth mode startup with exciting technology with potential to alter the quality of care of cardiac patients is looking for Supply chain management/ strategy leader. This position requires extensive experience across the end to end supply chain spectrum in Class 3 medical device industry. It requires proven track record of significant contributions to cost reduction and productivity improvement and experience in cross-functional leadership.