Associate Director, Quality Control

Lantheus Brand • Springfield, NJ

10d • Onsite

About The Position

Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we’re expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We’re dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Join us and be part of a company where your contributions make a real impact, because we know someone’s health is in our hands. This role will be based at Evergreen Theragnostic, a Lantheus company, located in New Jersey. We are seeking an Associate Director, Quality Control. The Associate Director, QC, acts as senior leadership for the Quality Control operation at Lantheus’ Evergreen site. This position will oversee and lead the QC department at Evergreen. This role will be accountable for governing the department in terms of function and responsibility as well as providing technical guidance/decisions (when needed) for the operational levels to ensure an efficient and structured operation that can cater to internal as well as external needs within the organization to deliver quality radiopharmaceutical products. This role will be the primary accountable person for the success of the QC department operations at Evergreen Theragnostics in terms of efficiency, skill retention and compliance. Ensures processes are designed and compliant per applicable cGMPs, procedures, and that processes are defined consistent with regulatory filings. This role must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices. The role will also be accountable for the review and authoring of key CMC submissions, along with setting relevant standards for analytical operations. This position is based in New Jersey and requires a presence on-site, three days per week, and open to applicants authorized to work for any employer within the United States.

Requirements

• Requirements include a B.S. in relevant scientific/technical disciplines, advanced degrees (e.g., MS) or technological certificates preferred but not required.
• 2+ years of experience in the radiopharmaceutical industry preferred but not required
• Minimum 10+ years experience in a GMP Quality Control Environment.
• Minimum 5+ years experience in people management and conflict resolution.
• Minimum 3+ years experience in defending QC operations against FDA and EMEA regulatory inspections.
• Previous experience with managing a microbiology department is preferred.
• Previous experience working with sterile filled/finished drug products, medical device, radiopharmaceuticals and CDMO management strongly preferred.

Nice To Haves

• Subject matter expert (SME) in various analytical test methods and analytical technology.
• Strong knowledge of global regulatory requirements related to the design and control of these processes.
• Knowledge of SOPs, cGMPs, GCPs and GLPs and the ability to work and manage within a regulatory environment.
• Demonstrated experience with the execution of technology transfer and scale up programs for commercial drug product analytical processes.
• Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing & testing.
• Excellent organizational skills and the ability to successfully manage a multitude of technical projects.
• Ability to work in a fast paced, complex and changing environment.
• Excellent analytical, technical and experiences.
• Proactive mindset with strong leadership, facilitation, teamwork, and influence management/negotiation skills.
• Understanding of FDA and/or EMEA quality and regulatory processes.
• Prior experience with regulatory filings is highly desired.
• Experience working with external partners is highly desirable.
• Ability to work independently in decision-making and resolution of program obstacles and conflicts.
• Keen insight, independent judgment and tactful discretion are required.
• Ability to function autonomously, with an appreciation of detail while being cognizant of “the big picture”.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required.
• Candidate represents Lantheus and the Evergreen site to external organizations and must exhibit the highest levels of personal integrity, quality, and professionalism.
• Travel may be required and is dictated by product needs and project deliverables, including overnight travel to CDMO locations.

Responsibilities

• Design, establish and maintain a standard QC operational structure with assigned roles and responsibilities that can be aligned with the needs of the organization.
• Oversee the creation and maintenance of a QC training matrix and program to ensure consistency in execution and retention of capability & skill.
• Define specific qualification standards for SMEs and the subsequent qualification processes.
• Manage mid-management (supervisors, managers etc) direction to ensure alignment of objectives and completion of deliverables by the department.
• Provide technical guidance and decisions to mid-management in order to be able to achieve the required objectives and deliverables.
• Design, maintain and defend the internal departmental processes to ensure compliance to cGXP requirements.
• Oversee and manage departmental efficiency and proficiency to enable a lean operation.
• Review and approve department related protocols, procedures, test methods, and studies as appropriate.
• Responsible to create, maintain and harmonize key business processes with internal and external stakeholders.
• Partner with the Internal and CDMO management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage.
• Partner with Business Development (BD) team in identifying and evaluating new technological platforms and pipeline products for Lantheus’ business growth.
• Partner with site operations to effectively deliver analytical services to meet product release timelines for future product supply.
• Partner with existing sites in the network to incorporate lessons learned from ‘sending’ sites for an optimized analytical process.
• Leads, motivate, mentor, and develops team members to exceed and meet company goals.
• Develop and maintain effective working relationships with other division groups and external partners in support of technology transfer, validation, and process support activities.
• Lead assigned operational personnel in owning Quality processes within the required responsibility of the department (i.e. Change controls, Investigations, CAPAs, Protocol & report writing)
• Responsible to review and co-author key CMC sections with external partners and cross functional stakeholders.
• Actively promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment. Report and take initiative to correct safety and environmental hazards.
• Actively demonstrate Lantheus’ values

Benefits

• Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award.
• Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage.
• Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits.
• In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees