Director, Intellectual Property

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>

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>

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Director, Intellectual Property

Lead Quality Specialist - Investigator

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Director, Intellectual Property

Lead Quality Specialist - Investigator

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