Logistics Assistant

Director, Intellectual Property

Lead Quality Specialist - Investigator

Quality Assurance Associate

Responsibilities:﻿ Proactive Disruption Management: <ul><li>Actively monitor ocean shipments, identifying potential disruptions before they escalate.</li><li>Use various tools to identify issues and take immediate action to communicate delays or disruptions to stakeholders.</li><li>Work directly with marine carriers, drayage providers, freight forwarders, ports and customers to resolve delays.</li></ul> Effective Communication: <ul><li>Serve as the primary point of contact for in-transit shipments with marine carriers, Customer Service Representatives (CSR), and Demand Resource Planners&nbsp;</li><li>(DRP) to communicate issues and implement corrective measures.</li><li>Ensure timely updates on shipment delays and disruptions are communicated to all stakeholders.</li></ul> Data-Driven Action: <ul><li>Regularly analyze shipment data to identify trends and potential disruption risks, developing proactive strategies to prevent delays.</li><li>Utilize tools including SAP, PowerBI, Excel, Visibility Vendors, etc. to extract and compare shipment data, ensuring real-time decision-making.</li></ul> Continuous Improvement: <ul><li>Proactively suggest process improvements related to data accuracy, carrier compliance, and system enhancements to minimize disruptions.</li></ul> Reporting and Analysis: <ul><li>Extract, summarize, and report findings on marine shipment data as needed, providing insights that support logistics operations and decision-making.</li><li>Track and trace business-specific requests, ensuring that all initiatives are aligned with improving shipment outcomes.</li></ul> Requirements: <ul><li>Bachelor’s Degree in Commerce, Science, Supply Chain, or Operations.</li><li>1-2 Years of Experience in Logistics or Supply Chain Operations.</li><li>Experience with SAP, Real Time Visibility Vendor, PowerBI, Excel, Salesforce, etc</li></ul>

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>

Responsibilities:Primary responsibilities of this role include the following:With Supervision, review documents/records and provide batch release authorization to 3PL service provider for products manufactured outside of the US.Support Drug Product Complaint management; forwarding to respective drug product manufacturing site and coordinate with corporate QA for investigations.Support Drug Product Recall/Field alert management.Assist with review of Quality Agreements.For applicable products, coordinate with Contract Testing Laboratories for Analytical Method Transfer activities, Drug Product testing, any OOS results, and test method issues.With supervision, review deviations/investigations related to the company's frontend products.Assist with SOP management for the company’s US corporate office.Support with quality matters for disposition of product returns.Assist during FDA inspections and local regulatory inspections at the company’s US corporate office.Requirements:Excellent verbal and written communication skills are necessary.With supervision and direction, effectively prioritizes competing tasks in a fast-paced and dynamic environment.Motivated, results driven with attention to detail, accuracy and clarity.Qualifications: BS degree in Pharmacy, Chemistry, Biology or Microbiology is preferred. 1-2 years of Quality Assurance or related pharmaceutical industry experience is preferred.Recent graduates will be considered for this role. 

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4 marine biology Jobs found

Logistics Assistant

Director, Intellectual Property

Lead Quality Specialist - Investigator

Quality Assurance Associate

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Logistics Assistant

Director, Intellectual Property

Lead Quality Specialist - Investigator

Quality Assurance Associate

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

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