Director, Intellectual Property

Instrument System Executive

Lead Quality Specialist - Investigator

Responsibilities:&nbsp; <ul><li>The successful candidate will contribute to the success of the company’s IP strategy by developing and maintaining the company’s patent portfolio.</li><li>Work with Research and Development to produce the most effective U.S. and foreign patent strategies and portfolios for company products and projects.</li><li>Work closely with Research and Development to identify patentable inventions. participate in internal invention disclosure assessments. provide guidance regarding the patentability of inventions under review.&nbsp;</li><li>prepare and prosecute high-quality, strategic patents (both utility and design).&nbsp;</li><li>assign and efficiently manage work performed by outside law firms. review applications and prosecution materials prepared by outside counsel. provide technical and legal commentary to ensure overall application quality.&nbsp;</li><li>work with the IP team to develop and implement patent strategies and processes. and work with R&amp;D and other departments to understand business priorities and challenges to incorporate those into a comprehensive IP strategy.</li><li>Support/lead in the development of patentability, validity, infringement, freedom-to-operate opinions, and requisite patent searching.</li><li>Monitor competitor activity, initiating and controlling measures to invalidate third-party patent rights.</li><li>Manage patent families and select patent portfolios on a global basis.</li><li>Education of internal research and development teams about company IP policies and the importance of IP.</li><li>Manage IP budget and set priorities for investment in intellectual property.</li></ul> Requirements: <ul><li>D.degree from an accredited law school.</li><li>Membership in good standing in at least one state bar.</li><li>Registration to practice before the USPTO.</li><li>Advanced Science Degree (Chemistry, Biology or Pharmacy).</li><li>At least 10 years of in-house legal experience and proven track record in IP management at a pharmaceutical company.</li><li>Ideal candidate will also have some experience with devices or with engineering.</li><li>Candidate should demonstrate very deep scientific understanding of chemistry and pharmaceuticals and an ability to rapidly acquire and apply new knowledge.</li><li>Experience with preparation, prosecution, and e-filing of U.S. and foreign patent applications.</li><li>Experience in all aspects of IP counseling, including freedom to operate and validity opinions.</li><li>Strong oral and written communication skills and attention to detail.</li><li>Strong analytical skills.</li><li>Excellent business judgment related to critical IP issues, and strategic thinking capability.</li><li>Ability to be flexible and provide critical and clear IP advice to internal client groups.</li><li>Strong organizational skills and ability to manage numerous projects simultaneously</li><li>The candidate will be located in Somerset, New Jersey.</li><li>Travel is required and the candidate should be prepared to regularly travel to the company’s Research and Development facilities in Florida and the Netherlands.</li></ul>

Responsibilities: <ul><li>Identify and recognise areas of KWS compliance.&nbsp;</li><li>Identify, recognise and implement KWS “best practices”</li><li>Identify areas of opportunity &amp; work with plant to correct.</li><li>&nbsp;Works with other plants to identify, develop and implement KWS “best practices”</li><li>Leads ongoing cross-functional teams to conduct plant savings opportunities analyses.</li><li>Owns Technician Training and development systems in support of Technician Progression</li><li>Responsible for Site Daily Meeting Cadence with Tier 1-4 meetings and insures they are healthy for results sustainability.</li><li>To guard standards and regulations on EHS, QFS and other fundamentals by participating in and coaching during Leader Led Observations, Safety 7, Golden 6, and other EHS and QFS activities. Provide support and involvement in all internal and external audits.&nbsp;</li><li>To develop and sustain a reliable maintenance system to ensure business continuity and effective cost control&nbsp;</li><li>To review technical KPIs and perform technical failure analysis for continuous improvement.&nbsp;</li><li>To lead and develop a comprehensive maintenance system with SAP integration.&nbsp;</li><li>Support 24/7 run production line. Primary contact point for technicians and Line Manager&nbsp;</li><li>To ensure all the plant maintenance is carried out as per schedule. Involved in all Corrective and Preventive execution.</li></ul> Requirements: <ul><li>Degree in Electrical/Electronic or related discipline with at least 7 years working experience.</li><li>Sound practical knowledge in control circuit, PLC, HMI and drives (Allen Bradley). Able to understand single line and control circuit diagram.</li><li>Preferably having work experience in F&amp;B industries with experience in SAP system</li><li>Technical experience in the following systems:&nbsp;</li><li>Programmable logic controllers and touchscreen operator panel, preferably Allen-Bradley Control Logic-based controller and Panel View system.</li><li>Digital sensory devices (e.g. capacitive/inductive/ magnetic/photoelectric sensor, electropneumatic actuator, etc)</li><li>Analog based (4-20 mA) process devices (e.g. load cell, RTD, piezoelectric, differential pressure, hydrostatic, radar, electropneumatic positioner, control valves, etc)</li><li>Ethernet-based communication devices (switch, data server, variable speed drives)</li><li>Full reading/drawing literacy of single-line diagram and control panel electrical wiring diagram.</li><li>Numerical literacy of basic electrical engineering (motor power, electrical load, cable sizing) and process engineering (basic mathematics related to the physics of pressure, temperature, level, force, etc)</li><li>Power distribution system and electrical safety regulation</li><li>Preferably with some process literacy in HVAC, compressed air supply, utility gas supply, potable and waste water treatment</li></ul>

Role Description: <ul><li>The Lead Quality Specialist - Investigator serves as the primary investigator for Out of Specification (OOS), Out of Trend (OOT), Non-Official Events (NOE), and other laboratory investigations within the Quality Control (QC) department.</li><li>This role is responsible for initiating, conducting, and closing laboratory investigations while collaborating with cross-functional teams to ensure accurate root cause analyses, effective Corrective and Preventive Actions (CAPAs), and adherence to compliance requirements.</li><li>Frequent interaction with QC, QA, Manufacturing, and other departments is essential to achieve timely investigation closure and process improvements.</li></ul> Scope of Authority <ul><li>Provides investigative and compliance support to the QC laboratory, with a focus on maintaining quality standards and supporting cross-departmental collaboration.</li></ul> Responsibilities; 1. Initiation, Execution, and Closure of QC Lab Investigations (60%) <ul><li>Initiate and conduct OOS, OOT, and NOE investigations in alignment with procedural timelines.</li><li>Provide support and guidance to QC teams during execution, writing, and closure of investigations.</li><li>Conduct interviews with QC personnel to gather information and complete investigation reports in Trackwise.</li><li>Utilize laboratory software for root cause and impact analyses.</li><li>Conduct quality walkthroughs in the QC laboratory to identify and address compliance issues.</li><li>Regularly communicate with departmental leaders to provide updates on investigation progress and documentation needs.</li></ul> 2. Corrective and Preventive Actions (CAPAs) (30%) <ul><li>Collaborate with cross-functional teams to identify, implement, and monitor CAPAs within QC laboratories.</li><li>Assist with training, procedure updates, and monograph revisions based on investigation outcomes.</li><li>Provide recommendations for process improvements to support continuous improvement initiatives.</li></ul> 3. Compliance (10%) <ul><li>Identify compliance risks, propose remediation strategies, and lead the implementation of solutions.</li><li>Provide compliance expertise, training, and support to QC and other impacted departments.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in Chemistry, Biology, or Pharmaceutical Sciences.</li><li>Minimum of 4 years of experience in a pharmaceutical manufacturing environment.</li></ul> Knowledge <ul><li>Proficiency in HPLC, GC, and related chromatography methods and equipment.</li><li>Working knowledge of Chromatographic Data Systems (e.g., Empower preferred) and applications such as Trackwise.</li><li>Comprehensive understanding of QC lab testing and data integrity principles.</li><li>Familiarity with regulatory requirements, including 21-CFR-210, 21-CFR-211, ICH Guidelines, and Compendia standards (USP, EP, JP, etc.).</li></ul> Skills &amp; Abilities <ul><li>Strong technical writing and documentation skills.</li><li>Problem-solving and decision-making expertise.</li><li>Excellent communication skills with peers, chemists, and senior management.</li><li>Critical thinking and root cause analysis proficiency.</li><li>Customer and stakeholder focus, with a strong commitment to quality and integrity.</li><li>Physical &amp; Mental Requirements</li><li>Ability to sit, stand, walk, and use a computer for extended periods.</li><li>Exposure to moderate noise levels and various chemicals in an FDA- and DEA-regulated environment.</li><li>Ability to wear personal protective equipment (e.g., gloves, respirators).</li><li>Specific vision requirements include close vision and color vision.</li></ul>

Skills

Industry

Location

Jobtitle

3 cell biology Jobs found

Director, Intellectual Property

Instrument System Executive

Lead Quality Specialist - Investigator

WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

Skills

Industry

Location

Jobtitle

3 cell biology Jobs found

Director, Intellectual Property

Instrument System Executive

Lead Quality Specialist - Investigator

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.