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

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

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

New

Pharmacy Technician

We’re building a world of health around every individual — shaping a more connec...

Location

United States , Selbyville

Salary:

16.50 - 25.00 USD / Hour

CVS Health

Expiration Date

August 09, 2026

Requirements

Must be at least 16 years of age
Licensure requirements vary by state
Attention and Focus
Customer Service Orientation
Communication Skills
Mathematical Reasoning
Problem Resolution

Job Responsibility

Manage all assigned pharmacy workstations and tasks to support the team’s ability to promptly, safely and accurately fill patient prescriptions all while providing caring service that exceeds customer expectations

What we offer

Medical, dental, and vision coverage
Paid time off
Retirement savings options
Wellness programs

Fulltime

New

Pharmacy Technician

We're building a world of health around every individual — shaping a more connec...

Location

United States , Akron

Salary:

17.00 USD / Hour

CVS Health

Expiration Date

August 09, 2026

Requirements

Must comply with any state board of pharmacy requirements or laws governing the practice of pharmacy, which includes but is not limited to, age, education, and licensure/certification
If the state board of pharmacy does not address or mandate a minimum age requirement, must be at least 16 years of age
If the state board of pharmacy does not address or mandate a minimum educational requirement, must have a high school diploma or equivalent, or be actively enrolled in high school or high school equivalency program
State-level licensure and national certification requirements vary by state, click here to learn more
Regular and predictable attendance, including nights and weekends
Ability to complete required training within designated timeframe
Attention and Focus: Ability to concentrate on a task over a period of time
Ability to pivot quickly from one task to another to meet patient and business needs
Ability to confirm prescription information and label accuracy, ensuring patient safety
Customer Service and Team Orientation: Actively look for ways to help people, and do so in a friendly manner

Job Responsibility

Living our purpose by following all company SOPs at each workstation to help our Pharmacists manage and improve patient health
Following pharmacy workflow procedures at each pharmacy workstation (i.e., production, pick-up, drive-thru, and drop-off) for safe and accurate prescription fulfillment
Contributing to positive patient experiences by showing empathy and genuine care: creating heartfelt and personalized moments while serving patients at pick-up, drive-thru, and over the phone
keeping patients healthy by offering immunizations and other services at the register and over the phone
and demonstrating compassionate care by solving or escalating patient problems
Completing basic inventory activities, as permitted by law, and as directed by the pharmacy leadership team, such as accurately putting away medication deliveries and completing cycle counts, returns-to-stocks, waiting bin inventories, etc.
Contributing to a high-performing team, embracing a growth mindset, and being receptive to feedback
actively seeking opportunities to expand clinical and technical knowledge needed to better assist patients
Remaining flexible for both scheduling and business needs, while contributing to a safe, inclusive, and engaging team dynamic
voluntarily traveling to stores in the market to work shifts as needed by the business

What we offer

medical, dental, and vision coverage
paid time off
retirement savings options
wellness programs

Fulltime

New

Pharmacy Technician Back End

We’re building a world of health around every individual — shaping a more connec...

Location

United States , Londonderry

Salary:

16.00 - 28.84 USD / Hour

CVS Health

Expiration Date

July 09, 2026

Requirements

Certification/licensed/registered pharmacy technician or as required by state law
One (1) or more years of experience as a pharmacy technician or equivalent experience
Verifiable High School Diploma or GED

Job Responsibility

Rotating and working in various assigned pharmacy workstations including: Packaging, Staging, Returns, Receiving, Narcotics, IV, Ekit, Compounding, Omnicell Cycle Fill, Machine Packaging
Receiving product deliveries, pull and stage product for distribution, rotate stock, and coordinate activities with drivers to ensure shipments are accurate and deliveries are timely
Performing physical inventories of medication

What we offer

Medical coverage
Dental coverage
Vision coverage
Paid time off
Retirement savings options
Wellness programs

Fulltime

New

Technical Business Analyst - Cards & Payment Networks

Are you a payments expert who speaks fluent ISO 8583 and loves deconstructing tr...

Location

United Kingdom , Burgess Hill

Salary:

65000.00 - 70000.00 GBP / Year

Randstad

Expiration Date

July 02, 2026

Requirements

7+ years of experience as a Technical Business Analyst specifically within the Payments domain
Deep, hands-on understanding of the Card Issuing & Acquiring lifecycles (Mandatory Skill)
Practical experience with Visa Base I/II/III, Mastercard CIS, or Amex systems
Deep expertise in ISO 8583, ISO 20022, and JSON APIs
Mastery of end-to-end authorization, clearing, settlement, and reconciliation flows
Solid grasp of PCI-DSS requirements, chargebacks, and dispute processing
Working knowledge of cryptography and PIN translation requirements

Job Responsibility

Gather complex business requirements and translate them into crystal-clear technical specifications, user stories, and acceptance criteria
Map data elements seamlessly across internal platforms and external payment networks
Drive scheme compliance and spearhead network certification testing (e.g., Mastercard MAS)
Define and validate comprehensive end-to-end payment test scenarios
Dive into data using SQL and log analysis to investigate and resolve complex transaction issues
Work closely with Engineering, QA, and Network teams within an Agile/Scrum framework

Fulltime

New

Pharmacy Technician

We’re building a world of health around every individual — shaping a more connec...

Location

United States , Westbrook

Salary:

17.10 - 27.10 USD / Hour

CVS Health

Expiration Date

August 01, 2026

Requirements

Must comply with any state board of pharmacy requirements or laws governing the practice of pharmacy, which includes but is not limited to, age, education, and licensure/certification
If the state board of pharmacy does not address or mandate a minimum age requirement, must be at least 16 years of age
If the state board of pharmacy does not address or mandate a minimum educational requirement, must have a high school diploma or equivalent, or be actively enrolled in high school or high school equivalency program
State-level licensure and national certification requirements vary by state
Regular and predictable attendance, including nights and weekends
Ability to complete required training within designated timeframe
Attention and Focus: Ability to concentrate on a task over a period of time
Ability to pivot quickly from one task to another to meet patient and business needs
Ability to confirm prescription information and label accuracy, ensuring patient safety
Customer Service and Team Orientation: Actively look for ways to help people, and do so in a friendly manner

Job Responsibility

Living our purpose by following all company SOPs at each workstation to help our Pharmacists manage and improve patient health
Following pharmacy workflow procedures at each pharmacy workstation (i.e., production, pick-up, drive-thru, and drop-off) for safe and accurate prescription fulfillment
Contributing to positive patient experiences by showing empathy and genuine care: creating heartfelt and personalized moments while serving patients at pick-up, drive-thru, and over the phone
keeping patients healthy by offering immunizations and other services at the register and over the phone
and demonstrating compassionate care by solving or escalating patient problems
Completing basic inventory activities, as permitted by law, and as directed by the pharmacy leadership team, such as accurately putting away medication deliveries and completing cycle counts, returns-to-stocks, waiting bin inventories, etc.
Contributing to a high-performing team, embracing a growth mindset, and being receptive to feedback
actively seeking opportunities to expand clinical and technical knowledge needed to better assist patients
Remaining flexible for both scheduling and business needs, while contributing to a safe, inclusive, and engaging team dynamic
voluntarily traveling to stores in the market to work shifts as needed by the business

What we offer

dental
vision
wellness resources
employee discounts
access to certain voluntary benefits
other programs

Parttime

New

Nursery Practitioner

Are you a dedicated Early Years professional looking for a setting where your ex...

Location

United Kingdom , Burgess Hill

Salary:

14.00 - 16.00 GBP / Hour

Randstad

Expiration Date

July 01, 2026

Requirements

Full and relevant Level 3 qualification in Early Years (e.g., NVQ Level 3, Cache Level 3)
Proven experience working with the 0-5 age range in a formal nursery setting
Thorough knowledge of the EYFS and statutory requirements
Strong initiative, with the ability to lead activities and mentor junior staff
Fully committed to safeguarding and promoting the welfare of children

Job Responsibility

Deliver age-appropriate activities and maintain precise observations and progress reports for key children
Create an inviting, educational indoor and outdoor space that sparks curiosity
Act as a professional point of contact for parents regarding their child's development
Maintain impeccable standards of health and safety, assisting with personal care and mealtime routines with dignity

What we offer

Competitive Salary
Paid on professional Practitioner scale
Access to advanced CPD, specialist training, and clear pathways to leadership
Supportive Culture
Collaborative team environment
Generous holiday allowance
Commitment to healthy work-life balance
Referral Bonus
Training and education
Safeguarding & Prevent

Fulltime

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Associate Director, CMC Operations

Job Description

Job Responsibility

Requirements

What we offer

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