Pharmaceutical Quality Engineer Senior

Major responsibilities include but are not limited to :

Perform Product and Process Trending, author reports and present at management review meetings.

Perform trending of all environmental monitoring and process utility data author quarterly reports and escalate any issues or adverse trends to Senior Management.

Calculate Contamination Recovery Rates (CRRs) for all Graded Manufacturing areas and personnel.

Independently perform Quality Assurance walkthroughs of classified manufacturing areas to observe and evaluate production activities, aseptic processes and the proper execution of Batch Production steps, identify any deficiencies and escalate critical issue to Senior Management

Lead the Alarm Reconciliation Program ensuring all facility Critical alarms generated are accounted for and proper root cause, corrective action, event assessment and trending is complete and accurate.

Update Quality Assurance standard operating procedures as required

Perform Gap assessments of corporate standards and guidance documents where required.

Perform other Quality related tasks such as deviation investigations and GEMBA assessments when required

Participate in programs for process improvements when required.

Basic Qualifications :

Bachelor's Degree and 5-10 years of relevant experience in Process trending and statistical control

Preferred Qualifications :

Ability to multitask.

Ability to work independently

Ability to interact and present information to upper level management

Working knowledge of Word, Excel, Minitab, PowerPoint or other data management applications

Ability to establish and maintain highly effective relationships with individuals from all levels of the organization.

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use .

I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role :

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.

By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.

Join Takeda as a Director, of Global Regulatory Affairs CMC where you will oversee the development and execution of regulatory CMC development and registration strategies.

You may manage staff members. As part of the Global Regulatory Affairs CMC team, you will work with Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff.

How you will contribute :

Demonstrate Takeda leadership behaviors.

Independently manage regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities.

Participate in global teams that require experienced interpretation of applicable EMA / FDA / ICH / WHO / Global regulations to ensure CMC compliance.

Evaluate change proposals for regulatory impact and filing requirements.

Lead team members that establish CMC content (data and documentation) requirements for regulatory submissions and will review this content for conformance with established requirements.

Lead and contribute to business process development.

Evaluate new business development opportunities or represent Global Regulatory Affairs CMC on due diligence teams.

Maintain constructive relations with essential colleagues, e.g. colleagues within Takeda, Alliance Partners, and Health Authority representatives.

Ensure that project team colleagues, line management, and partners are informed of developments that may affect regulatory success.

Elevate and communicate actual or potential issues to line management.

Successfully communicate and negotiate with international Health Authorities, directly and indirectly.

Represent Takeda Global Regulatory Affairs CMC in Health Authority meetings and lead CMC preparation activities for meetings with Health Authorities on CMC-related matters.

Manage and support staff, if required, including staff professional development and project oversight.

What you bring to Takeda :

BS / BA Degree in a Scientific Discipline, Advanced Degree preferred.

10+ years of pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience, with international experience strongly preferred.

Experience liaising with Regulatory Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred.

Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.

Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams.

Ability to deal with issues of critical importance provides regulatory advice and makes reasoned decisions on regulatory issues for which there may not be clear / specific regulatory guidance.

Demonstrated leadership, problem-solving ability, flexibility, and teamwork.

Good judgment in elevating and communicating actual or potential issues to line management.

Excellent written and oral communication skills.

Experience of active participation in Agency / Industry groups / forums expected.

Travel Requirements :

Willingness to travel to various meetings, including overnight trips.

Requires approximately up to 10-30% travel.

This position is currently classified as hybrid in accordance with Takeda’s Hybrid and Remote Work policy.

Base Salary Range : $156,800 to $224,000 based on the candidate's professional experience level. Employees may also be eligible for Short-Term and Long-Term Incentive benefits as well.

Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

What Takeda can offer you :

Comprehensive Healthcare : Medical, Dental, and Vision

Financial Planning & Stability : 401(k) with company match and Annual Retirement Contribution Plan

Health & Wellness programs including onsite flu shots and health screenings

Generous time off for vacation and the option to purchase additional vacation days

Community Outreach Programs and a company match of charitable contributions

Family Planning Support

Flexible Work Paths

Tuition reimbursement

More about us :

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs.

Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.

We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine :

Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals?

Come do your best work alongside other innovative, driven professionals in this meaningful role.

Global Quality Compliance Auditor (Pharmaceutical)

Live

What you will do

Let’s do this! Let’s change the world!

Responsible for executing Global Quality Compliance Audits and assigned tasks and / or projects necessary to achieve corporate and departmental goals including the following activities :

• Coordinates, leads, or participates in Corporate Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, and Critical Service providers, to assess compliance with all applicable regulations and to identify top compliance risks.
• Assesses state of compliance with appropriate regulations and lead or participates in the assessment of action plans to correct deficiencies.
• Ensure completion, maintenance and sustainability of the assigned training per specific roles to support the audit process (e.

g., read and understand how to apply regulatory requirements including changes to regulations, guidelines and standards, trends and expectations, as applicable).

• Has documented experience and working knowledge of Amgen’s competencies including but not limited to manufacturers or intermediates, API / drug substance, drug product, combination products, medical devices, and laboratories.
• Provides leadership toward escalating site and multi-site compliance issues resulting from audit findings.
• Serves as subject matter expert on global regulated requirements and inspectional commitments, as applicable.
• Provides support for domestic and international Regulatory Authority Inspections when necessary.
• Provides technical support / compliance review of multi-site / global documents resolving compliance issues, if / when necessary.
• Interacts with other functional leads to ensure that Amgen Standards, strategies and direction are aligned with existing regulations and regulatory expectations.
• Alerts senior and / or executive management of significant quality, and compliance risks.
• Provides support for audit and inspection metrics as necessary.
• Supports Continual Improvement initiatives, programs and projects.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The compliance professional we seek will posses these qualifications.

Basic Qualifications :

Doctorate degree

Master's degree and 3 years of compliance experience

Bachelor's degree and 5 years of compliance experience

Associate's degree and 10 years of compliance experience

Highschool diploma / GED and 12 years of compliance experience

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $99,994.00 to $122,102.00.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work / life balance, and career development opportunities including :

• 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 and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancers, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win.

Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request accommodation.

Berkeley Research Group

BRG currently has over 40 offices across the United States and internationally. This position will be based in either BRGs Washington, DC, Boston, MA or New York, NY office.

BRG Healthcare Analytics professionals bring extensive industry experience to deliver data driven, independent, and innovative approaches to complex legal, regulatory, and business challenges.

Our core strength is the ability to harness and analyze large amounts of electronic healthcare data and turn it into meaningful and insightful information.

Healthcare companies trust our independent thinking and ability to solve unstructured problems. We serve a range of healthcare clients including payors, providers, life sciences companies, and the legal and financial firms that work with the industry.

TheManaging Consultantrole is a mid-to-senior level consulting staff position.This role will work within the practices pharmaceutical and life sciences team, supporting projects that involve financial modeling and valuation.

This position requires highly motivated problem solvers with solid analytical abilities, strong organizational skills, and a desire to advance within the organization.

The work will involve both execution and oversight of engagement work streams that may be either qualitative or quantitative in nature, and responsibilities include management of junior staff, design of pharmaceutical pricing and forecast analysis, modeling of financial data and markets, quality control, development and presentation of client deliverables, management of existing client relationships, industry research, and expansion of business.

Job title and compensation to be determined based on qualifications and experience.

Responsibilities

• Demonstrate creativity and efficient use of relevant software tools, analytical methods and computer models to develop solutions.
• Plan and manage all aspects of small to medium sized client engagements and discrete segments of larger projects.
• Delegate assignments to staff, instruct and monitor progress, and review work product for completeness and accuracy.
• Develop analyses and financial models using transactional data and / or financial data.
• Design and generate client deliverables and make valuable contributions to expert reports.
• Manage client relationships and communicate results and work product as appropriate.
• Prioritize assignments and responsibilities to meet goals and deadlines.
• Participate in group practice meetings, contribute to business development initiatives and office functions such as staff training and recruiting.
• This position is based in BRGs Washington DC, New York, Tampa, or Boston offices working with colleagues in the office three to four days a week, on average.

Basic Qualifications

• Bachelor's degree or equivalent, and an undergraduate level understanding of economics, finance, accounting, statistics, econometrics, or other related subject.
• MBA in Pharmaceutical sales and marketing or Financial Planning is highly preferred.
• 4-6 years of work experience with a focus in healthcare data analytics.
• Experience and subject matter expertise in pharmaceutical pricing and forecast analysis and pharmaceutical sales and marketing.
• Ability to work with pharmaceutical data sets, including IQVIA data, claims data, distributor sales data and gross-to-net calculations.
• Experience with EU data a plus
• Strong technical skills, including the ability to independently execute complex data analytics in at least one programming language (e.

g., SQL, SAS, SPSS, Stata, R, etc.).

• Demonstrate strong verbal and written communication skills.
• Desire to work in a team environment and supervise team members.
• This is a hybrid position and the candidate will be working with colleagues in the office three to four days a week, on average.

Candidate must be able to submit verification of his / her legal right to work in the U.S., without company sponsorship.

Managing Consultant Salary Range : $100,000 $230,000per year

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ThinkBRG

BRG is an Equal Employment Opportunity / Affirmative Action Employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

PI223599053

Seeking software engineers to work closely with computer scientists, chemists and biologists to develop software that will enhance research efforts.

This is an excellent opportunity with an established company offering an excellent compensation and benefit package.

Requirement : Requirements :

Requirements :

• Linux / Unix experience
• Programming / Scripting

experience is required such as Python, C / C++, Perl, Fortan or other programming / scripting languages

• A background in natural science
• MS in Computer Science or related field. PhD preferred. Will consider PhD candidates in Natural Sciences who have software development experience.

Desired experience :

• a background in computer-aided design, molecular modeling, chemical databases, or SVL programming is desired.
• Experience with sofware packages such as InstantJChem, MarvinBeans, MOE, Prime, MacroModel, or Glide is desired.