Senior Manager, Global Supply Chain

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to advance novel therapies for obesity and related conditions.
 
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You'll Do:

The Senior Manager, Global Supply Chain reports to the Director, Global Supply Chain and possesses a working understanding of clinical supply management and project management practices. The Senior Manager, Global Supply Chain will support the Director, Global Supply Chain and Global Supply Chain team to ensure uninterrupted supply of Investigational Medicinal Product (IMP) for clinical studies as well as inventory of comparator drug products (if applicable).

Required location: San Diego, CA (onsite or hybrid 2-3 days per week).

Responsibilities:

• With minimal supervision, manage and support investigational drug product supply and logistics activities, including, but not limited to, demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, returns, reconciliation, destruction, cold chain management, and inventory management
• Monitor inventory levels ensuring no shortage of IMP throughout the life of a clinical trial
• Manage of packaging and labeling/distribution vendors, including relationship management
• Manage preparation of clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, coordinating the origination, proofing, and translation of clinical study labels and generation
• Proactively identifying potential issues, notifying supervisor in a timely manner, and developing mitigating actions
• Interpret clinical synopses and protocols to create clinical IMP demand forecasts
• Attend clinical study and cross functional meetings as needed
• Oversee the execution of multiple clinical trials and proactively identify potential supply chain issues and recommend solutions to global supply chain
• Manage clinical study close-out activities, including returned goods, reconciliation, and inventory destruction
• Support drug supply delivery through coordination of CMC efforts (including, but not limited to, CMC, Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations)
• Support temperature excursion processes are executed as required
• Support IRT System development. Lead development of user requirement specifications and management module(s) as applicable
• Support organization and filing of documents on SharePoint sites

Required Qualifications:

• Experience with pharmaceutical development and manufacturing operations for development-stage products
• 8+ years of relevant biopharmaceutical industry experience with 5+ years in hands-on clinical supply management
• Knowledgeable in the implementation and workings of IRT systems
• Ability to create a collaborative environment and manage multiple project activities
• Strong computer skills including MS Office
• Hands-on, roll-up-your-sleeves, collaborative approach with high sense of urgency and drive for results
• Ability to think outside of the box and challenge the status quo
• Desire to work in a fast-paced, innovative environment

Preferred Qualifications:

• Injectable drug experience

Education:

• Bachelors degree in pharmaceutical science, engineering, life sciences, or other relevant field or equivalent experience

Benefits of Working at Kailera

In addition to traditional benefits, we provide enhanced offerings designed to support the well-being and financial security of our team members and their families.

• Comprehensive health benefits and tax-advantaged savings accounts
• Flexible time off, 13 paid holidays, and a companywide year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Disability and life insurance

At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: 

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify:

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

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