Biopharmaceutical Specialist Job at Amgen (Taipei)

GMP QC Specialist, CMC

Reporting to the Director, QA Operations, the GMP QC Specialist, CMC, will be re...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in scientific discipline
Advanced degree preferred
Minimum of 5 years’ hands-on experience in biopharmaceutical technical operations, QC operations and/or quality operations
Minimum of 2 years’ hands-on experience in GMP laboratory environment, with specific familiarity with cell and gene therapy release assay development, performance, and qualification
Specific experience performing or reviewing microbiological assays, including compendial methods (sterility, endotoxin, mycoplasma assays, APS, APV and Environmental Monitoring)
Experience interacting with external testing laboratories preferred
Working knowledge of GMP and ICH guidance and both US and international regulatory requirements
Highly organized, effective, and proactive communicator verbally and in writing. Able to work independently to appropriately prioritize work
Strong team orientation and passion for continuous self-development
Experience in industry or in a startup industrial setting is preferred

Job Responsibility

GMP Compliance: Ensure that all internal laboratory activities are maintained in accordance with internal data integrity practices and standards. Ensure that external laboratory activities comply with GMP regulations and guidelines. Stay current with regulatory requirements and industry standards related to GMP
Batch Review / Release: Perform full batch record review of all types of investigations
perform appropriate quality control review of all QC data generated by third parties
draft, review, and approve CoA (internal/external)
Investigations: Identify issues of non-compliance and work directly with the third party to resolve prior to batch release. Review and approve any out-of-specification investigations in a timely manner
Quality Control Procedures: Develop, implement, and maintain quality control procedures to monitor and assess internal laboratory processes, as well as the processes employed by external laboratories used to generate QC data. Conduct regular reviews to identify areas for improvement and initiate corrective action(s) as needed
Audits and Inspections: Assist in the planning and conducting of internal audits to assess compliance with data integrity standards and approved procedures (e.g. SOPs, test methods). Support audits of external laboratories as needed
Assay Qualification / Validation: Review and approve assay development, qualification and validation plans, data generated and reports. Provide primary QC support for all activities
Documentation Management: Oversee the creation, review, and approval of laboratory documentation, including SOPs, test methods, protocols, and reports. Ensure that the documentation is accurate, complete, and in compliance with GMP requirements. Ensure all Process Development (Analytical Development and Manufacturing Sciences & Technology) related documentation and data are reviewed and archived in a timely and accurate manner
Training and Education: Assist in providing training and guidance to Process Development personnel on GMP principles, procedures, and compliance requirements. Ensure that all team members are informed and adhere to quality control measures

What we offer

health and retirement
PTO
stock option plans

Biopharmaceutical Specialist- Oncology (CRC/LC Focus)

The Biopharmaceutical Specialist – Oncology (CRC/LC Focus) is a pivotal role in ...

Location

Taiwan , Taipei

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Minimum 3 years of pharmaceutical sales experience, preferably in Oncology, with CRC/LC experience strongly preferred
Bachelor's degree in science or medical-related field, preferably with higher qualifications in pharmacy science
Demonstrated growth mindset, strategic thinking, and results orientation
Strong cross-functional collaboration, and communication skills
Proactive, enthusiastic, and creative approach, with a strong ability to take initiative
Fluency in English for both oral and written communication
Proficient in computer skills, including MS Office programs

Job Responsibility

Achieve sales target of responsible hospital assigned oncology accounts with a primary focus on CRC/LC-related hospitals and key centers
Establish and maintain high-quality customer relationships
Coordinate and implement scientific events aligned with marketing strategy
Demonstrate in-depth knowledge of oncology diseases (with emphasis on CRC/LC), products, market, stakeholders, and competitors
Attend required training sessions, obtaining necessary certifications, and participating in conventions and symposia
Collaborate with others to enhance coordination in promotional efforts
Complete call reporting, updating territory report and expense reports

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Qa quality specialist

This position reports to the Associate Director, External Quality, Quality Syste...

Location

Ireland , Cork

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in science or engineering
Minimum 3+ years of biopharmaceutical experience in a Quality, Compliance, and/or Regulatory setting
Skilled in data analysis and excel
Strong communication and interpersonal skills – Oral, written and presentation skills
Works collaboratively with others to meet shared objectives.

Job Responsibility

Perform the Quality Systems Metric Review for External Quality and oversee relevant metrics and trending for each quality system to proactively drive on-time closure of Quality records
Responsible for managing routine cross-functional meetings to ensure timely closure of Deviations, CAPAs and Change Control, with leadership endorsement
Responsible for development/reporting of metrics and supporting standardization of these across the Organization
Co-ordinate monthly governance site quality review team (SQRT) meeting for GEO / External Quality
Deliver training on Quality Management Systems, as required
Partner with the Global Quality Systems Management Team and other cross functional groups to ensure proper application of the QMS
Identify and implement continuous improvement initiatives to the External Quality systems
Assist as needed in audits and inspections
Participate in development and implementation of global alignment projects with BioMarin’s sister sites
Manage the Self Inspection Programme for External Quality

Senior QA Specialist – Supplier Audits

This role is instrumental in strengthening supplier quality and compliance acros...

Location

United States , California

Salary:

Not provided

Mantell Associates

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences, Engineering, Chemistry, or related discipline
Significant experience in supplier quality, audits, and quality systems within a pharmaceutical, biopharmaceutical, or CDMO environment
Strong knowledge of cGMP, ICH, regulatory expectations, and quality risk management principles
Demonstrated ability to lead supplier audits and effectively communicate findings to technical and operational stakeholders
Excellent analytical, report writing, and interpersonal skills with a proactive, solutions-oriented mindset
Ability to travel as required to support supplier audit activities (domestic and, occasionally, international)

Job Responsibility

Plan, execute, and lead supplier audits (on-site and remote) in accordance with cGMP, ISO standards, and internal procedures
Evaluate supplier quality systems, processes, corrective actions, and risk controls to ensure compliance and robust supply continuity
Prepare comprehensive audit reports, findings, and recommendations, and drive closure of audit observations with stakeholders
Support supplier qualification activities, including documentation review, risk assessments, and technical evaluations
Collaborate with Quality, Procurement, Regulatory, and Manufacturing teams to escalate supplier risks and implement mitigation strategies
Maintain audit schedules, quality intelligence, and supplier performance metrics to support continuous improvement
Serve as a subject matter expert on supplier quality expectations, training internal partners as needed

Fulltime

Commercial Excellence & Operations Japan Specialist

Lead impactful commercial excellence initiatives and drive operational efficienc...

Location

Japan , Tokyo

Salary:

5000000.00 - 7200000.00 JPY / Year

Randstad

Expiration Date

May 07, 2026

Requirements

Bachelor's degree or equivalent in a relevant field
Minimum 3 years of experience in commercial excellence/sales excellence roles, with a focus on SFE, business analytics, or strategic planning
Proven experience with CRM tools (ideally Salesforce) and BI tools (e.g., Qlik)
Advanced proficiency in Microsoft Excel and PowerPoint
Excellent communication skills in both Japanese and English (business level proficiency required)
Experience in the life sciences, medical devices, or biopharmaceutical industry is a plus
Strong analytical skills and attention to detail
Ability to work independently and as part of a team
Demonstrated ability to manage multiple projects simultaneously

Job Responsibility

Partner with commercial teams to optimize territories and customer segmentation
Develop and maintain accurate, up-to-date information within CRM and BI systems
Create insightful analyses and reports to track performance and support key business decisions
Build strong relationships with global and local stakeholders
Develop and deliver training materials and SOPs

What we offer

Health insurance
Employee pension insurance
Employment insurance
Bonus (+10%)

Fulltime

Key Account Manager - Cardiovascular

Join Amgen’s Mission of Serving Patients. The Cardiovascular Account Manager wil...

Location

United States , Hartford; Stamford; Meriden; Danbury; Norwalk; New Haven

Salary:

169832.00 - 201841.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 2 years of sales experience and/or related account management experience
Master’s degree & 4 years of sales experience and/or related account management experience
Bachelor’s degree & 6 years of sales experience and/or related account management experience
3+ years of account management and/or public payor experience strongly preferred
Advanced degree (e.g. MPH, MBA, PharmD, etc.) 7+ years of healthcare sales and/or marketing experience or related experience in buying processes and decision making
Clinic, hospital, dyslipidemia, heart failure, access environment, applicable competitors, and industry experience preferred
Cardiology experience, including dyslipidemia, heart failure and acute coronary syndromes, highly preferred
A solid understanding of the current environment and trends in community cardiology practices.
Understanding of the internal and external dynamics in both dyslipidemia and heart failure (e.g.: inpatient to outpatient management and protocols, readmission programs, Electronic Management systems, performance vs quality metrics, CHF/interventional performance priorities)
District Management Experience preferred

Job Responsibility

Assess and diagnose the current business environment in each of their assigned accounts in relation to Amgen Cardiovascular products and plan/execute actions for success in these accounts
Work internally through the matrix team, and externally with customers to develop strong relationships for Amgen to support portfolio performance and brand strategies at multiple touch points and levels within complex partner organizations
Key account strategic lead
Develops and executes innovative strategies to reach difficult to access health care providers and accounts in a compliant manner
Maintains comprehensive account profile / needs assessment / strategic plan
Responsible for routinely meeting with appropriate opinion leaders in Cardiology, Lipidology, Pharmacy, P&T Committee, etc., that act as partners or decision-makers within the Health System Manager assigned accounts
Presents MAC approved data and CV product messaging for approved CV products and delivers clinical messages compliantly within all governing policies
Accountable for ensuring formulary adoption in targeted / assigned hospital accounts to help drive appropriate utilization of approved CV products
works with other sales colleagues to lead and coordinate pull-through and access
Monitors Amgen business performance across Cardiovascular portfolio

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

MSAT Bioprocess Specialist

We are working with a leading biopharmaceutical manufacturer who are seeking an ...

Location

United Kingdom , Falkirk

Salary:

Not provided

SRG

Expiration Date

Until further notice

Requirements

BSc (Hons) or equivalent in a Science or Engineering discipline
Proven GMP biologics manufacturing or process development experience
Strong organisational and stakeholder influencing skills
Demonstrated project management capability and ability to meet deadlines
Experience in process scale‑up/transfer and providing manufacturing support
Effective communication across all levels
Experience evaluating materials for process suitability and writing GMP batch records

Job Responsibility

Lead the technology transfer of new and existing biologics processes into GMP manufacturing
Prepare, review, approve and issue GMP manufacturing documentation, including batch records
Define scale‑up criteria and develop process mass balances and flow diagrams
Specify large‑scale equipment and assess material suitability for GMP use
Generate quality documentation for raw materials and equipment
Work within the site Quality Management System, raising and managing change controls
Conduct and close investigations, deviations and CAPAs
Project manage the introduction of processes into manufacturing from end to end
Perform risk assessments aligned with ICH Q9 principles
Collaborate cross‑functionally with MSAT, Development, Manufacturing, QA, Supply Chain, Engineering and Project Management teams, as well as relevant external partners

What we offer

Competitive package
Extensive benefits package

Key Account Manager - Cardiovascular

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , Indianapolis

Salary:

169832.00 - 201841.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 2 years of sales experience and/or related account management experience
Master’s degree & 4 years of sales experience and/or related account management experience
Bachelor’s degree & 6 years of sales experience and/or related account management experience
3+ years of account management and/or public payor experience strongly preferred
Advanced degree (e.g. MPH, MBA, PharmD, etc.) 7+ years of healthcare sales and/or marketing experience or related experience in buying processes and decision making
Clinic, hospital, dyslipidemia, heart failure, access environment, applicable competitors, and industry experience preferred
Cardiology experience, including dyslipidemia, heart failure and acute coronary syndromes, highly preferred
A solid understanding of the current environment and trends in community cardiology practices.
Understanding of the internal and external dynamics in both dyslipidemia and heart failure (e.g.: inpatient to outpatient management and protocols, readmission programs, Electronic Management systems, performance vs quality metrics, CHF/interventional performance priorities)
District Management Experience preferred

Job Responsibility

Assess and diagnose the current business environment in each of their assigned accounts in relation to Amgen Cardiovascular products and plan/execute actions for success in these accounts.
Work internally through the matrix team, and externally with customers to develop strong relationships for Amgen to support portfolio performance and brand strategies at multiple touch points and levels within complex partner organizations.
Key account strategic lead
Develops and executes innovative strategies to reach difficult to access health care providers and accounts in a compliant manner
Maintains comprehensive account profile / needs assessment / strategic plan
Responsible for routinely meeting with appropriate opinion leaders in Cardiology, Lipidology, Pharmacy, P&T Committee, etc., that act as partners or decision-makers within the Health System Manager assigned accounts
Presents MAC approved data and CV product messaging for approved CV products and delivers clinical messages compliantly within all governing policies
Accountable for ensuring formulary adoption in targeted / assigned hospital accounts to help drive appropriate utilization of approved CV products
works with other sales colleagues to lead and coordinate pull-through and access
Monitors Amgen business performance across Cardiovascular portfolio

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

Biopharmaceutical Specialist

Amgen

Location:
Taiwan , Taipei

Category:
Sales

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
December 18, 2025

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