Associate Quality Control (Analytical) Job at Amgen (Singapore)

Associate Director, Quality Control – Analytical Sciences

We are seeking an Associate Director to join the QC Analytical Sciences team in ...

Location

United States

Salary:

165000.00 - 185000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry, microbiology or related field)
7+ years of analytical development & quality control experience with complex biologics spanning early and late-stage development (GMP experience required)
Expertise/competence in several relevant analytical techniques such as HPLC, spectrophotometry, mass spec, ELISA, bioassay and microbiology
Strong understanding of global regulatory requirements (e.g., FDA, EMA, ICH) as they relate to analytical development, QC testing, and method validation
Hands-on experience supporting regulatory submissions (INDs, IMPDs, BLAs/NDAs, or equivalents), including preparation, review, and response to analytical sections
Excellent communication skills with an ability to collaborate effectively across functional lines
Ability to work independently and multi-task in a fast-moving organization
Availability to participate in calls across multiple international time zones
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Position requires up to 30% travel including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year

Job Responsibility

Support the harmonization of QC analytical methods across internal laboratories, external vendors, and contract testing organizations
Partner with global and cross-functional teams to ensure successful implementation of harmonized methods
Support method transfers, validations, and comparability studies, ensuring adherence to regulatory and quality requirements
Provide technical oversight to vendors and contract laboratories, including troubleshooting and resolution of method-related issues
Author and review regulatory submissions (e.g., INDs, BLAs, MAAs) and support technical documentation, ensuring clarity, accuracy, and compliance with global guidelines
Generate and review technical documents, including protocols, reports, and method lifecycle documents

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

Associate Director, Analytical Development and Quality Control

The Associate Director, Analytical Development and Quality Control will support ...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

10+ years of experience, or 5+ with advanced degree, in the pharmaceutical/biotech industry with experience in all phases of innovative drug development and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.)
Strong expertise in analytical techniques HPLC/UPLC, LC–MS, SE-HPLC, dissolution, along with extractables and leachable analysis
Knowledge of drug development activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements
Hands-on experience supporting early- and late-stage CMC development, stability programs, and specification setting
Proven experience leading OOS/OOT investigations, deviations, CAPAs, and change controls
Strong track record of working with CROs/CMOs and managing external analytical/testing activities
Excellent technical writing skills for analytical reports and regulatory submissions (IND/IMPD, NDA/BLA)
Demonstrated leadership ability with experience mentoring and developing scientific staff
Strong communication, cross-functional collaboration, and project-management skills
Innovative team-player with high energy for our dynamic company environment

Job Responsibility

Support analytical development and QC activities related to characterization of drug substances and drug products from early-stage clinical development through commercialization
Maintain current knowledge in analytical methods and control strategies supporting a variety of molecule platforms and dosage forms
Oversee and provide scientific leadership on QC testing for DS/DP at vendors, ensuring cGMP compliance, data integrity, and timely delivery of analytical results
Direct investigations including OOS/OOT, deviations, and CAPAs, and provide strong analytical rationale
Design and manage stability programs (accelerated, long-term, bracketing/matrixing) supporting early and late clinical phases
Interpret stability trends and establish shelf-life/retest periods consistent with ICH guidelines and peptide behavior
Support comparability assessments for process changes, analytical method updates, or site transfers
Communicate CMC project status to key stakeholders cross-functionally and assist in driving decision-making
Participate in cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed
Author and review CMC sections of IND/IMPD and NDA submissions and address regulatory questions

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

Quality Control Associate

This is a Finance position responsible for monitoring the quality of perishable ...

Location

United States , Hartford

Salary:

23.00 USD / Hour

Sysco

Expiration Date

Until further notice

Requirements

High school diploma or general education degree (GED)
Prior warehouse, inventory control or merchandising experience
Proficient in Microsoft Office
Effective written/oral communication skills
Strong analytical skills

Job Responsibility

Provide technical, customer relations, and personnel management for major programs and projects
Check produce in slots on a daily basis to make a certain product that is set up for shipping is up to acceptable standards
Communicate regularly with necessary parties on the company’s status on product quality
Communicate with Inventory Control Manager or Compliance Manager and buyers all quality issues and assists them in resolving them to ensure the customer receives the highest quality products possible
Monitor variance reports for accurate accounting of spoilage, warehouse damage, truck damage, etc.
Inspect inbound freight, warehoused product, and/or outbound product and document product condition
Analyze, identify, and propose action to the solution of problems associated with Quality Assurance
Observe all safety rules, regulations, and sanitation policies

Fulltime