Associate Director, CMC Operations Job at Kailera Therapeutics (Waltham)

Director, Product Quality Leader

This individual will serve as a technical quality expert for one or more product...

Location

United States

Salary:

164000.00 - 225500.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

BA/BS in life sciences or related field required
Advanced degree desirable
12+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry
Preferred experience in biologics product development and licensure or technical support
Experience in both clinical and commercial phases of product lifecycle is highly desirable
Experience supporting combination products across clinical and commercial stages, including device quality considerations, is a plus
Excellent interpersonal and communications skills
Demonstrated strong leadership capability
Experience with influencing diverse stakeholders and driving accountability and decision-making in a highly matrixed, cross-functional environment
Highly capable of building strong, effective working teams

Job Responsibility

Serve as a technical quality expert for one or more products during clinical development through post-commercialization
Make technical quality-related decisions
Serve as the single point of contact on the CMC team for all quality functions, risks and issues
Provide efficient and effective quality leadership of CMC-related strategic activities
Drive associated quality decisions
Participate fully in CMC team meetings and other relevant technical forums
Partner with CMC Team and the Quality organization to identify, develop and prioritize long-term product strategies/initiatives
Accountable for creation of the product-specific Quality strategy
Lead the cross-functional Quality Partner Team (QPT) supporting Quality-related CMC deliverables
Own and manage the product quality risk register

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

Associate Director, Global Supply Chain

The Associate Director, Global Supply Chain reports to the Senior Director, Glob...

Location

United States , Waltham, MA or San Diego, CA

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 10+ years of relevant biopharmaceutical industry experience or advanced degree with 5+ years of experience
6+ years of experience in 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
Ability to travel up to 20%

Job Responsibility

Assist with 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
Maintaining oversight in monitoring inventory levels throughout the life of a clinical trial
Support with oversight of packaging and labeling/distribution vendors, including relationship management
Coordinate the preparation of clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, and coordinating the origination, proofing, and translation of clinical study labels and generation
Proactively identify potential issues, notify supervisor in a timely manner, and develop mitigating actions
Interpret clinical synopses and protocols to create clinical IMP demand forecasts
Attend clinical study and cross functional meetings as needed
Assist the global supply chain lead in overseeing the execution of multiple clinical trials and proactively identify potential supply chain issues and recommending solutions to global supply chain lead
Lead clinical study close-out activities, including returned goods reconciliation and inventory destruction
Assist with 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)

What we offer

comprehensive health coverage
flexible time off
paid holidays
year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

Associate Director, Global Supply Chain

The Associate Director, Global Supply Chain reports to the Senior Director, Glob...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 10+ years of relevant biopharmaceutical industry experience or advanced degree with 5+ years of experience
6+ years of experience in 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
Ability to travel up to 20%

Job Responsibility

Assist with 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
Maintaining oversight in monitoring inventory levels throughout the life of a clinical trial
Support with oversight of packaging and labeling/distribution vendors, including relationship management
Coordinate the preparation of clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, and coordinating the origination, proofing, and translation of clinical study labels and generation
Proactively identify potential issues, notify supervisor in a timely manner, and develop mitigating actions
Interpret clinical synopses and protocols to create clinical IMP demand forecasts
Attend clinical study and cross functional meetings as needed
Assist the global supply chain lead in overseeing the execution of multiple clinical trials and proactively identify potential supply chain issues and recommending solutions to global supply chain lead
Lead clinical study close-out activities, including returned goods reconciliation and inventory destruction
Assist with 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)

What we offer

comprehensive health coverage
flexible time off
paid holidays
year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

Director, CMC and Device Regulatory Affairs

The Director, CMC and Device Regulatory Affairs will lead the implementation of ...

Location

Salary:

220000.00 - 240000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Advanced degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field
Minimum of 10 years of industry experience
At least 6 years in CMC regulatory for biologics and/or drug-delivery combination products
Experience with late-stage development (Phase 3) and/or BLA/MAA/Notified Body submissions preferred
Proven track record of leading cross-functional submission teams and successful regulatory submissions
Strong knowledge of global regulatory requirements (FDA, EMA, ICH)
Excellent communication, leadership, and project management skills
Detail-oriented with ability and desire to work in a fast-paced, nimble, hands-on, team-oriented, biotech environment
Up to 15 – 20% travel is required, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless

Job Responsibility

Develop and implement global CMC and device regulatory strategies for assigned program(s)
Lead the preparation and review of CMC and device regulatory submissions (e.g., INDs, CTAs, BLAs, MAAs, Notified Body submissions)
Collaborate with Technical Operations, Quality, Clinical, and Regulatory teams to ensure regulatory requirements are integrated into product development plans
Identify regulatory risks associated with product development and propose mitigation strategies
Manage interactions with regulatory agencies and notified bodies, including meeting preparation and responses to queries
Review CMC-related changes for potential impact on global submissions, provide regulatory impact assessments, and work with project teams to ensure timely reporting of changes
Archive and maintain regulatory submissions and correspondences in Apogee’s regulatory information management system
Contribute to the optimization and implementation of processes and procedures, commensurate with departmental and company growth

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

New

Seasonal team member

Longleat is seeking enthusiastic and customer focused Seasonal Team Members to j...

Location

United Kingdom , Longleat

Salary:

10.30 - 12.21 GBP / Hour

Longleat Enterprises Limited

Expiration Date

March 08, 2026

Requirements

A passion for delivering a great guest experience and willing to go out of your way to do so
Good team player with excellent interpersonal skills
Ability to remain calm and efficient under pressure
Excellent communication skills with a confident and friendly nature
Be honest, reliable and committed, and enjoy responsibility and exceeding expectations
You must be aged 16 or over, and above school leaving age to apply for this role
For Attractions Team Member role: applicants must be aged 18 or over
For Guest Experience Team Member role: Experience in a customer service environment is required

Job Responsibility

Food and Beverage Team Member: Delivering outstanding service at varied food outlets
Attractions Team Member: Supporting animal team with giraffe feeding, marshalling seasonal events, ensuring guest safety on rides
Retail Team Member: Engaging with guests, helping pick souvenirs, serving on till
Cleansing Team Member: Ensuring the park remains clean and presentable, focusing on guest toilet blocks
Ranger: Providing a clean and presentable environment, waste disposal, traffic management
Guest Experience Team Member: Welcoming guests at arrivals booths, resolving enquiries, meeting VIP guests, responding to questions via email, social media, or telephone

What we offer

29 days holiday inclusive of bank holidays, rising to 31 days at 5 years’ service
Unlimited free entry to Longleat for our employees
Complimentary tickets to Longleat and Cheddar Gorge and Caves, 18 per annum pro rata
50% off Membership for Friends and Family
Discounts on food and beverages and retail merchandise
Discounts on VIP Experiences and Accommodation
Discretionary bonus scheme
Employee Assistance Programme
Employer contributory pension scheme
Life assurance scheme

Fulltime

!

New

Planermill Supervisor

You are a natural leader with the proven ability to adapt and remain flexible in...

Location

United States , El Dorado

Salary:

Not provided

Canfor

Expiration Date

Until further notice

Requirements

Minimum 3-5 years of supervisory experience in an industrial environment
Working knowledge of web-based computer applications and Microsoft Office
Grade 12 or equivalent
Valid driver's license

Job Responsibility

Maintain the highest safety standards, ensuring compliance with all policies, procedures, practices, and OSHA regulations
Address unsafe conditions promptly and proactively
Identify opportunities to improve processes and reduce costs while safely meeting production targets
Coach, train, and support team members to maximize performance
Foster open communication and engage employees for input into work processes and systems
Ensure timely implementation of key corporate and operational initiatives, and assist in equipment troubleshooting
Maintain and monitor production goals
Work with other departments to achieve operational goals

Fulltime

New

Customer Service Representative

As a Customer Service Representative, you will embark in a 12- week training pro...

Location

United States , Mt Sterling

Salary:

17.15 - 25.73 USD / Hour

Dot Foods

Expiration Date

Until further notice

Requirements

High School Diploma
Excellent verbal and written communication skills
Proficient in Microsoft programs such as Office, Word, and Excel
Ability to process a high volume of request (email/phone) at a fast, accurate pace

Job Responsibility

Manage customer questions and requests by providing appropriate solutions, ensuring timely and accurate response and resolution
Act as the liaison between the customer and multiple internal departments, including Replenishment, Pricing, Accounts Receivable, and Transportation
Process customer orders to ensure internal order deadlines are completed on time
Go above and beyond to meet customer needs, including appropriate use of empathy
Work closely with a team to include, outside sales, regional teammates, and internal customers
Applies lean thinking and tools to identify and eliminate waste in all areas of the position

What we offer

Significant advancement opportunities
Potential to work from home after 1 year

Fulltime

New

Seasonal forestry opportunity

Every year, Canfor hires numerous Forestry Field Assistants to join us in term p...

Location

Canada , Prince George

Salary:

47600.00 - 68000.00 / Year

Canfor

Expiration Date

Until further notice

Requirements

Current or past enrollment in a forestry or natural resources management program, and/or forestry work experience
Excellent communication skills and an ability to perform physically demanding fieldwork in a team environment
A valid Class 5 Driver’s License

Job Responsibility

Timber stratification and preliminary feature identification using Lidar data and imagery
Road and cutblock layout
Site level plans and ecosystem data collection
Operational cruising
Field information mapping stream and riparian assessments
Supervision of planting, vegetation management, and site preparation activities to ensure compliance with safety, environmental, and quality standards
Completion of post-harvest prescriptions and regeneration surveys
Updating key Silviculture databases following completion of activities
Conducting both field and office activities which relate to Planning
Conducting field surveys and assessments to support block design and reconnaissance efforts

What we offer

paid leave
health & well-being programs

Fulltime

Associate Director, CMC Operations

Kailera Therapeutics

Location:
United States , Waltham

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 15, 2026

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