Senior Manager, Commercial Packaging

Vera Therapeutics Inc.•Brisbane, CA

41d•$123,000 - $186,000

About The Position

Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical development, and MAU868, a monoclonal antibody designed to neutralize infection with BK virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com. Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do-from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases. Position Summary: The Senior Manager, Commercial Packaging will report to the Sr. Director, Commercial Supply Chain Management and will be responsible for responsible for all aspects of Finished Goods (FG) packaging operations and transport engineering, including the oversight and management of Contract Manufacturing Organizations (CMOs). Working with the CMC team and key personnel including Quality Assurance, Supply Chain, Regulatory and Marketing, the ideal candidate must be an outstanding leader with a proven track record of strategic planning and execution in biologics packaging operations having supported product launches, directed packaging operations and managed lifecycle changes of commercial packaged goods. In addition, the role requires experience with artworks management and transport qualification of temperature controlled supply chains from Drug Substance to Finished Goods. The candidate must have exceptional organizational and communication skills, be capable of communicating strategic plans to upper management, summarize data, and effectively manage interactions with stakeholders across functions.

Requirements

MS in relevant life sciences or M Eng. in relevant engineering discipline preferred with a minimum of 5 years of Pharmaceutical/Biotechnology industry experience in cGMP manufacturing operations of biologics, or BS in relevant life sciences or engineering discipline with a minimum of 8 years of Pharmaceutical/Biotechnology industry experience in cGMP manufacturing operations of biologics.
Experience in managing US/international CDMOs for the packaging of cGMP drug product is required.
Knowledge of global serialization and track-and-trace processes is required. Certification or previous experience with TraceLink systems is preferred.
Experience validating and overseeing temperature controlled global transportation lanes.
Familiarity with packaging standards (ASTM, ISTA, ISO), container closure integrity (CCI), and stability testing protocols.
Working knowledge of FDA and international cGMP regulatory guidelines and submissions.
Proven leadership and cross-functional management of CMC-related programs. Track record of successfully driving and managing programs, overcoming challenges, and managing risks.
Critical thinking and problem-solving skills with ability to drive risk-based decision making.
Strong organizational and project management skills, including proficient use of MS Project and other tools.
Excellent communication and interpersonal skills in working across the organization.

Nice To Haves

Experience in commercial rapid-launch scenarios is desirable.
Certification or previous experience with TraceLink systems is preferred.

Responsibilities

Direct day-to-day external (CMO) packaging operations, including projection of material requirements, budgets, and timelines.
Manage technical oversight and guidance to CMOs for packaging technology transfers, optimization, and cGMP packaging of biologics drug product in support commercial supply.
Act as subject matter expert and project manager for packaging process validation, shipping distribution validation both in real-world and laboratory simulation environments.
Manage the transport qualification of temperature controlled shipment of goods across the end-to-end supply chain.
Oversee and manage the operation and configuration of Level 4 Track-and-Trace systems. Understand market and regulatory requirements from FDA, EMA and other global jurisdictions.
Manage the creation, update and obsoletion of printed components artwork partnering with Regulatory, Marketing, CMOs and third party printer/converters.
Execute plans in accordance with cGMP, ICH, and FDA regulations.
Write, update and review relevant sections for regulatory submissions.
Partner with and maintain regular contact with key stakeholders including Drug Product, Analytical Sciences, Quality Assurance, Regulatory Affairs, Finance, and Program Management.
Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents.