About the Job
The Strategic Ops Lead is designed to complement and support the responsibilities of the Site Enablement and Product Operations team within Strategic Operations. This role offers professionals in cancer diagnostics the opportunity to contribute to strategic initiatives, operational planning, and cross-functional coordination, while gaining exposure to leadership and product development processes.
Key Responsibilities
Support the Site Enablement and Product Operations Team in coordinating cross-functional activities across LabOps, Supply Chain, Client Services, and Quality.
Assist in documenting operational requirements and supporting data-driven decision-making.
Contribute to communications and stakeholder engagement across Strategic Operations and Product Development. · Participate in strategic initiatives and project planning, with a focus on scalability and patient impact.
Help track progress toward project team objectives and key results.
Coordinate the execution of E2E activities.
Attend and contribute to meetings, workshops, and collaborative sessions.
Provide insights and recommendations based on prior experience in cancer diagnostics.
Champion collaboration and operational agility across teams.
Other duties as assigned.
Qualifications:
Basic Qualifications:
Bachelor's degree and 2+ years of experience in the cancer diagnostics field
Strong communication and collaboration skills
Ability to manage time effectively across dual responsibilities
Preferred Qualifications:
Masters degree and 1+ years of experience in the cancer diagnostics field
Experience with Next Generation Sequencing (NGS)
Experience writing technical documentation, including laboratory verification plans
Familiarity with product development and design control processes
Demonstrated ability to work in cross-functional and global teams
Agreement to maintain confidentiality regarding sensitive company, employee, and proprietary data and information
Commitment to reflect Foundation Medicine's values: Integrity, Courage, Passion
The expected salary range for this position based on the primary location of Boston, MA is $70,900 - $88,600 per year. The salary range is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.
#LI-Hybrid
$70.9k-88.6k yearly Auto-Apply 12d ago
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Director, Reimbursement Operations
Foundation Medicine 4.8
Foundation Medicine job in Boston, MA
About the Job
The Director of Reimbursement Operations develops and implements strategies that ensure service excellence, high-performing team collaboration and overall operational health. The incumbent leads initiatives to enhance revenue cycle operations and fosters a comprehensive, ROI-driven approach to FMI's prioritization of revenue opportunities.
Key Responsibilities
Manage partnership with third-party vendor to maintain a high-performing revenue cycle team.
Collaborate across the Revenue & Access and vendor leadership teams to identify opportunities that impact revenue cycle performance.
Manage and oversee the activities supporting the full revenue cycle:
Commercial Health Plan Credentialing
Medicare Provider Credentialing
Medicaid claims and payment enrollment at vendor
Contract review (redline), set up and communication to vendor
Annual PAMA submission
Payer analytics
Reimbursement and outcomes
ROI activity
Model billing fees/annual and long-range planning
Invoice review and approval
Quarterly write-offs - analysis oversight and approval
Participate in team huddles
Special projects
Develop, implement, and manage metrics to measure and enhance performance.
Support field teams with customer meetings.
Analyze financial data to identify trends and areas of improvement in the reimbursement process.
Management and development of direct report(s).
Other duties as periodically assigned.
Qualifications
Basic Qualifications
Bachelor's degree in Healthcare Information or related fields, or equivalent work experience
10+ years of professional work experience
5+ years managerial experience
5+ years of experience in healthcare and medical billing
Extensive experience with pivot tables to aggregate and analyze large financial datasets, identifying key trends and insights. Proficient in creating financial models, charts, and visualizations to inform critical financial decisions; highlight expertise in structuring complex spreadsheets for clarity.
Preferred Qualifications
Master's or other Advanced Degree
Experience working within deadline and resource constraints
Prior experience working with intercultural teams
Demonstrated ability to lead an existing team of employees at different levels of their career
Ability to guide individuals and groups toward desired outcomes, setting high performance standards and delivering leading quality services
Ability to prioritize as necessary in a fast-paced environment
Ability to work well under pressure while maintaining a professional demeanor
Analytical thinking and solutioning skills
Effective and clear communication and presentation skills
Strong inter-personal skills with the ability to work cross-functionally to accomplish objectives
Willingness to adapt and work in ambiguous and/or changing conditions
Understanding of HIPAA and importance of privacy of patient data
Commitment to reflect FMI's values: Integrity, Courage, Passion
#LI-Hybrid
$99k-148k yearly est. Auto-Apply 60d+ ago
Vaccine Key Customer Leader - Central CA
Merck 4.6
Remote or Boston, MA job
Under the guidance of the Director, Commercial Operations-Vaccines, the Vaccine Key Customer Leader (VKCL) is the primary Vaccine point of contact for our company with assigned large private and public sector customers within their designated market. The VKCL engages with C-/ D-suite customers in assigned accounts and collaborates with the extended company field team to ensure implementation and pull-through at the individual clinic/hospital/provider level.
**Responsibilities include and are not limited to the following:**
+ The VKCL will be accountable for the Vaccines business performance, business relationship and customer experience with assigned customers, coordinating appropriate company resources and personnel to meet the needs of the customer.
+ Actively develops, enhances and applies a deep understanding of assigned customers, the local market healthcare /vaccination ecosystem, and ensuing interplay and translates into potential business opportunities.
+ Demonstrates and applies in-depth knowledge of the vaccination landscape including: vaccination schedule, quality measures, reimbursement processes, key factors affecting uptake, local immunization registries, coalitions, school requirements.
+ Responsible for demonstrating strong collaboration and coordination with all company customer-facing roles. With all assigned accounts, the VKCL will be responsible for building a Vaccines account strategy focused on increasing appropriate use of our company's Vaccines and coordinating the account team execution consistent with the strategy and customer needs.
+ Identifies key vaccine decision-makers and influencers, understands their concerns and priorities, builds trusting relationships that differentiate our company.
+ Collaborates with internal and customer stakeholders to formulate approach and select/deploy solutions to meet customer needs.
+ Identifies strategic customers within region/geography that afford our company differentiated business opportunities and prioritizes their importance.
+ Stays abreast of competitor approaches and our company's customer contracting strategy; engages appropriate account team members (field and HQ) to capitalize on opportunities to grow/defend the Vaccine business.
**Education Requirements:**
+ Required: BA/BS
+ Preferred: MA/MS/MBA in Business, Marketing, Science, Healthcare or Public Health
**Required Experience:**
+ Minimum of five (5) years experience in Sales leadership, Key Account Management / Client Service Management, Marketing, and/or Strategy preferably in the Healthcare industry
+ Minimum of two (2) years experience working in Sales leadership or Strategic Account Management with key thought leaders or high influence customers in Public Health, Large Group Practices, Hospitals/Systems, or Managed Care Organizations
+ Ability to build and develop customer relationships, including the ability to influence senior levels of management and key thought leaders
+ Excellent interpersonal and communication skills, with ability to interact with individuals from a variety of cultures, and disciplines
+ Strong peer leadership and ability to collaborate with and coordinate activity among individuals in different reporting structures within the organization
+ Self-motivated with the ability to perform with a high level of independence
+ Innovative thinking and exceptional business acumen, analytical and problem-solving skills
+ Proficient in Microsoft Excel, PowerPoint, Word and Outlook
+ Valid Driver's License
+ Travel (25%) varies based on candidate's location within the geography.
**Preferred Experience:**
+ Minimum of two (2) years experience working in/with Vaccines; strong understanding of Vaccination (products, processes, marketplace)
+ Recent Local Market and Customer Knowledge
+ Experience in a strategic or management role in Public Health or Health System/Medical Group
+ Strong understanding of compliance-related concepts including the laws and regulations that govern Pharmaceutical/Vaccine Marketing and Sales activities
**Required Skills:**
Accountability, Accountability, Account Management, Business Opportunities, Client Management, Commercial Account Management, Consumer Relations, Contract Management, Customer Experience Management, Customer Management, Customer Needs Analysis, Customer Relationship Management (CRM), Data Analytics, Executive Management, Financial Acumen, Healthcare Trends, Identifying Sales Opportunities, Independent Thinking, Interpersonal Relationships, Key Account Planning, Lateral Leadership, Leadership, Managed Care Marketing, Market Research, Profit Planning {+ 5 more}
**Preferred Skills:**
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$169,700.00 - $267,200.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** .
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
Domestic
**VISA Sponsorship:**
No
**Travel Requirements:**
25%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
Yes
**Hazardous Material(s):**
n/a
**Job Posting End Date:**
01/12/2026
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R377859
$169.7k-267.2k yearly 12d ago
Researcher, Talent Acquisition (Contract)
Foundation Medicine 4.8
Foundation Medicine job in Boston, MA
About the Job
The Researcher, Talent Acquisition leads and performs research activities for executive level, management level, and hard-to-fill positions within Foundation Medicine. This role independently uses a range of sourcing skills including research, networking, and candidate development to identify the best talent for Foundation Medicine across all functions.
Key Responsibilities
Conduct research to map Foundation Medicine's markets and generate candidate names and profiles.
Identify industry trends and insights to inform the creation of robust search strategies that will attract the best candidates for Foundation Medicine to consider.
Partner effectively on searches with TA leaders across the team. Successfully collaborate on team-based recruiting efforts to meet the hiring demands of the business.
Calibrate candidates with recruiters and/or hiring managers.
Build a proactive pipeline of talent for critical functions/industries.
Maintain data integrity in our candidate management system.
Initial candidate outreach and screening for basic qualifications.
Contribute to the knowledge base of the Talent Acquisition team by providing education on industries and talent pools/profiles.
Draw off knowledgeable industry sources to develop pools of candidates.
Participate in client update meetings on active searches and prepare reports.
Think outside of the box, pivoting search strategies as needed.
Leverage analytics from both internal and external tools/resources to innovate and improve our current executive search and Talent Acquisition systems and processes.
Provide strategic guidance and advice in partnership with Talent Acquisition and executive leadership.
Identify and showcase exceptional diverse talent to be considered for opportunities at Foundation Medicine.
Other duties as assigned.
Qualifications:
Basic Qualifications:
Bachelor's Degree
3+ years of recruiting or human resources experience, with 1+ year(s) of experience in talent research/pipelining
Preferred Qualifications:
3+ years of progressively responsible experience in talent research, either for an in-house executive search team in a highly demanding, fast-paced company, or in a large retained executive search company or boutique
Life sciences industry experience
Established history of delivering quality senior-level candidate flows that have led to successful hires
Deep expertise in leveraging LinkedIn Recruiter, LinkedIn Insights, Google, and other tools to source candidates
Demonstrated success with and passion for using various sourcing techniques
Ability to work autonomously and as part of a team
Ability to meet growing pipeline demand in a dynamic environment
Demonstrated acumen and passion for executive search and talent acquisition
Demonstrated experience in setting priorities and effectively managing multiple projects
Exceptional research, executive sourcing, and assessing skills
Effective oral and written communication skills with the ability to convey complex concepts with senior level executives in a polished and professional manner
High attention to detail with a strong sense of urgency
Hands-on and detailed approach to key initiatives and activities execution
Skilled at conflict resolution and problem-solving to achieve win-win outcomes
Understanding of HIPAA and importance of privacy of patient data
Commitment to reflect Foundation Medicine's values: Integrity, Courage, Passion
The expected compensation for this position based on the primary location of Remote is $40 - $55/hour. The hourly rate is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance.
#LI-Remote
$40-55 hourly Auto-Apply 12d ago
Director, Environmental Health & Safety
Sarepta Therapeutics 4.8
Bedford, MA job
Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits, see our website: *******************************
The Importance of the Role
The Director of EHS is a senior leader responsible for shaping and driving Sarepta's global EHS strategy. Reporting to the Vice President of Facilities, Engineering, and Capital Assets, this role will serve as the principal authority on EHS policies, compliance, and risk management across all sites. The Director will lead the development and execution of a comprehensive EHS management system, ensuring alignment with business objectives and regulatory requirements.
This position will oversee a growing team of EHS professionals and will be accountable for building organizational capability, fostering a proactive safety culture, and positioning EHS as a strategic partner in business decision-making.
The Opportunity to Make a Difference
Strategic Leadership: Define and implement a forward-looking EHS vision, strategy, and roadmap that supports Sarepta's business growth and operational excellence.
Executive Partnership: Act as a trusted advisor to senior leadership, influencing risk-based decisions and integrating EHS considerations into corporate strategy.
Program Development: Establish and maintain a robust EHS management system, ensuring compliance with all applicable laws, regulations, and industry best practices.
Team Building: Recruit, develop, and lead a high-performing EHS team, fostering a culture of accountability, innovation, and continuous improvement.
Risk Management: Oversee programs for occupational safety, industrial hygiene, environmental compliance, sustainability, and emergency preparedness.
Incident Command: Serve as Incident Commander during emergency response and recovery efforts; provide technical expertise for crisis management.
Enterprise Oversight: Direct EHS operations across Massachusetts and Ohio sites, with additional support for other business entities as needed.
More about You
Bachelors degree required, Master's degree in Industrial Hygiene, Occupational Safety, Environmental Science, or related field preferred.
Minimum 12-15 years of progressive EHS leadership experience, including at least 5 years in a senior management role within biopharmaceutical or chemical research environments.
Professional certifications strongly preferred: CIH, CSP, or CHMM.
Deep knowledge of OSHA, NFPA, EPA, and other federal, state, and local regulations.
Proven success in implementing enterprise-level EHS systems and programs, including emergency response, hazardous materials management, biosafety, and sustainability initiatives.
Exceptional communication and influencing skills, with the ability to engage stakeholders at all levels.
Recognized for leadership qualities aligned with Sarepta's core values: Drive, Excellence, Resilience, Teamwork, Innovation, and Compassion.
What Now?
We're always looking for solution-oriented, critical thinkers.
So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
#LI-Onsite#LI-CM1This position requires work on site at one of Sarepta's facilities in the United States.The targeted salary range for this position is $180,000 - $225,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.Candidates must be authorized to work in the U.S.Sarepta Therapeutics offers a competitive compensation and benefit package.Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
$180k-225k yearly Auto-Apply 21d ago
Sr. QA Engineer, CAPA
Foundation Medicine 4.8
Foundation Medicine job in Boston, MA
About the Job
The Sr QA Engineer (CAPA) plays a critical role in maintaining and improving Foundation Medicine's quality systems. The role conducts day to day administration of the CAPA process, coordinating the review, documentation and retention of quality records. The Sr QA Engineer, CAPA exercises considerable latitude to prioritize daily activities in a fast-paced environment, monitoring for timely completion of tasks and escalating any potential risks to ensure timely completion of CAPA deliverables. The position coordinates a variety of related tasks, assuming different activities when priorities change and interacting with all departments within Foundation Medicine to support the effectiveness of the CAPA Quality System.
Regular onsite work at a designated Foundation Medicine location is an essential function of this role.
The Sr QA Engineer (CAPA) is an experienced professional with wide-ranging skillsets to assist and support with the CAPA System at Foundation Medicine. The role will report to the Quality Assurance CAPA manager and will conduct day to day administration of the CAPA process, coordinate the review, documentation and retention of quality records. The Sr QA Engineer, CAPA will exercise considerable latitude to prioritize daily activities in a fast-paced environment, monitor for timely completion of tasks and escalate any potential risks to ensure timely completion of CAPA deliverables. The desired candidate is able to coordinate a variety of related tasks, assume different activities when priorities change and interact with all departments within Foundation Medicine to support the effectiveness of the CAPA Quality System.
Key Responsibilities
Develop and maintain an effective corrective and preventive action program.
Monitor CAPA phases and associated due dates to ensure timely progression and closure.
Facilitate cross-functional root cause analysis using tools like 5 Whys, Fishbone, and FMEA.
Provide technical writing guidance and ensure documentation is compliant with GxP, FDA, CLIA, CAP, ISO 13485, and other applicable standards.
Facilitate the CAPA Review Board (CRB), including preparation of materials, coordination of meetings, and documentation of decisions.
Monitor CAPA effectiveness and ensure timely follow-up.
Support audits and inspections by providing CAPA-related documentation and responses.
Collaborate with stakeholders in Operations, R&D, Regulatory Affairs, and Clinical teams.
Identify trends and systemic issues through data analysis and recommend process improvements.
Assist with reporting Key Performance Indictors (KPIs).
Other duties as assigned.
Qualifications:
Basic Qualifications:
Bachelor of Science degree or equivalent years of experience in technical or engineering discipline
3+ years of experience in CAPA management within a regulated environment (biotech, pharma, or diagnostics)
5+ years of related professional experience
Preferred Qualifications:
5+ years of Quality Assurance experience; preferably in the medical device or pharmaceutical industry with CAPA management experience.
Strong understanding of quality systems and regulatory requirements (GxP, IVD, FDA, ISO, CLIA, CAP)
Proficiency in quality tools and methodologies (e.g., 8D, DMAIC, Six Sigma)
Excellent communication, documentation, and project management skills
Experience with electronic quality management systems (eQMS)
Understanding of HIPAA and importance of privacy of patient data
Commitment to Foundation Medicine's values: Integrity, Courage, and Passion
The expected salary range for this position based on the primary location of Boston, MA is $100,320 - $125,400 per year. The salary range is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.
#LI-Hybrid
$100.3k-125.4k yearly Auto-Apply 60d+ ago
Pathologist - Per Diem (Active Full Medical License For Massachusetts)
Foundation Medicine 4.8
Foundation Medicine job in Boston, MA
About the Job The Pathologist is involved in all aspects of Foundation Medicine's laboratory operations and serves as an internal subject matter expert, applying medical knowledge to advise decisionmakers in support of Foundation Medicine's mission to transform cancer care. The Pathologist is responsible for review and approval of documentation and
reports, supporting clinical testing strategies, as well as new assay development and validation. The
Pathologist also serves as an ambassador for comprehensive genomic profiling through education and
research efforts within and external to Foundation Medicine.
This position is part-time (under 20 hours per week) and may be assigned to work during any time that
the laboratory is operational including evening and/or weekend hours.
Regular onsite work at a designated Foundation Medicine location is an essential function of this role.
Key Responsibilities:
* Participate in specimen review for all clinical and biopharma testing performed at Foundation Medicine including
FoundationOneCDx, FoundationOneHeme, and FoundationOneLiquid assays.
* Review Hematoxylin and Eosin stain (H&E) stained slides for specimen adequacy prior to nextgeneration sequencing and immunohistochemistry testing.
* Interact with the information technology teams to ensure appropriate functioning of software tools
and integrity of clinical data and reports.
* Assist in the development, training, and orientation of laboratory personnel in pathology review.
* Maintain availability to work during times that the laboratory is operational including evening
and/or weekend hours.
* Other duties and responsibilities as assigned.
Qualifications:
Basic Qualifications:
* Doctor of Medicine Degree
* Active Medical Licensure
* Formal pathology training
* American Board of Pathology - Anatomic Pathology Certification
Preferred Qualifications:
* 1+ years of experience evaluating images, including developing and running assays
* Subspecialty training and/or expertise in cancer biology, genomics or clinical trials
* Strong history of achievement demonstrated by leadership activities, publications, presentations
or other activities
* Collaboration skills and the ability to effectively communicate (written and oral) with internal and
external team members on project activities
* Process-oriented, flexible mindset and approach to creative problem solving
* Demonstrated history of cross-functional leadership and/or participation in cross-functional teams
* Demonstrated ability of meeting deadlines
* Understanding of the Health Insurance Portability and Accountability Act (HIPAA) and the
importance of patient data privacy
* Ability to work well under pressure while maintaining a professional demeanor
* Ability to self-organize and operate effectively without day-to-day oversight, while staying tightly
connected to key leaders and teams across the collaborations
* Ability to work in a laboratory environment in the presence of chemicals and reagents
* Commitment to reflect Foundation Medicine's values: Integrity, Courage, Passion
The expected compensation for this position based on the primary location of Boston, MA is $175 - $250/hour. The hourly rate is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance.
#LI-Onsite
$101k-165k yearly est. 51d ago
Sr. Nonconformance Specialist
Foundation Medicine 4.8
Foundation Medicine job in Boston, MA
About the Job
The Nonconformance Specialist is responsible for overseeing the identification, documentation, investigation, and resolution of nonconformances within Foundation Medicine's QA LabOps Team. This role ensures that all nonconformance events are managed in compliance with regulatory standards and internal policies, driving continuous improvement and supporting a culture of quality and accountability.
The Nonconformance Specialist collaborates with laboratory staff, quality assurance professionals, and management to ensure timely and effective corrective and preventive actions (CAPA) are escalated when required and Nonconformances (NCR) are closed on time. This position supports the execution of multiple projects and is accountable for achieving related business goals.
Key Responsibilities
Drives and oversees all nonconformance management activities to ensure compliance with applicable regulatory agencies and internal standards, including organizing, facilitating, and participating in investigations and resolution processes.
Monitor trends and provide data to leadership.
Inform department leadership of unfavorable trends before they result in noncompliance.
Track phase turnaround time for all nonconformances.
Lead and develop trainings on root cause analysis and nonconformance process.
Coordinate root cause, investigation, and phase overdue meetings with stakeholders.
Maintain complete and accurate records of nonconformance events, ongoing documentation for audits, and tracking corrective actions to resolution.
Establish internal nonconformance management processes and ensure proper documentation and training.
Manage the triage of new nonconformances and ensures proper assignment to the correct QA Approver.
Promote internal and external customer satisfaction and a culture of service excellence by meeting the customer's quality expectations.
Provide detailed reports to the Sr. Director on feedback and suggestions on the Veeva NCR system.
Conduct root cause analysis and implementation of correction, corrective and preventive actions, and verification of effectiveness as required.
Provide training and mentorship to less experienced members of QA staff across the QA organization.
Ensure the work climate/culture within Quality System exemplifies our Company's Leadership behaviors.
May assist in special projects, including site implementations and other activities as required.
Other duties as assigned.
Qualifications:
Basic Qualifications:
Bachelor's Degree or equivalent experience
3+ years of experience in Nonconformance management within a regulated environment (biotech, pharma, or diagnostics)
5+ years of related professional experience
Preferred Qualifications:
Advanced degree in the sciences, engineering, business, or a related field
ASCP or MT(AMT) Certification
ASQ Certification
Experience supporting a CLIA, QC, and laboratory
Experience with next generation sequencing methodology; knowledge of molecular biology
Experience with IVD, or Medical Device product development, analytical validation and product approval
Demonstrated experience in overseeing initiatives and/or resources dedicated to laboratory safety and associated regulatory guidelines
Evidence of practical knowledge of standards and regulations pertaining to the medical device industry, both domestic and international
Demonstrated ability to lead, communicate, interact, and influence effectively at technical levels across functions
Demonstrated capacity to work in a fast-paced environment with strong attention to detail
Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one's own workflow
Demonstrated ability to consistently meet or exceed project deadlines
Demonstrated ability to maintain confidentiality of business and proprietary information
Demonstrated knowledge of bioanalytical assay development, qualification, and validation requirements that comply with current regulatory standards
Strong collaboration skills with the ability to work with multiple stakeholders in a matrixed environment and to adjust accordingly to accommodate changing priorities
Strong skills in troubleshooting and problem solving
Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving with other departments and colleagues
Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint
Proficiency in relevant analytical methodology and emerging new technologies
Understanding of HIPAA and importance of patient data privacy
Commitment to reflect Foundation Medicine's values: integrity, courage, and passion
The expected salary range for this position based on the primary location of Boston, MA is $89,900 - $112,400 per year. The salary range is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.
#LI-On-site
$89.9k-112.4k yearly Auto-Apply 12d ago
Chromatography Expert
Merck 4.6
Bedford, MA job
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
Chromatography Expert
Your role: We are seeking a Chromatography Expert with an engineering background to support Protein A chromatography adoption by our clients. This is a customer facing role as part of a global Protein A focused team, where you will work in close partnership with MilliporeSigma's Account Managers to cater to client's technical needs which may include direction on PD trials and optimization, pilot and process-scale runs, column packing guidance, and troubleshooting issues that arise during operations.
You will serve as a key technical contact supporting biopharmaceutical clients with critical chromatography purification projects. Your responsibilities are to:
· Provide expertise to support clients with process development, scale-up, and implementation of JSR chromatographic resin used for antibody purification, via remote consultation or on-site support.
· Design and execute experimental protocols to understand process sensitivity and troubleshoot operational issues with minimal supervision. Critically analyze data and model process behavior to characterize process performance or troubleshoot root cause. Clearly communicate recommendations to GMP biopharmaceutical customers.
· Assist and train clients with resin column packing.
· Serve as key interface with Sales, R&D, and Marketing teams to communicate Voice of the Customer and Market Trends.
· Travel requirement up to 30%
Minimum Qualifications:
· Bachelor's of Science in Chemical Engineering or Biotechnology with 10+ year's related experience OR Master's of Science in Chemical Engineering with 8+ year's related experience OR PhD in Chemical Engineering or Biotechnology with 5-7+ years' experience.
· 5-7+ years practical experience with downstream biologics purification in a manufacturing or process development environment, including a knowledge of scale-up, process transfer, and cGMP manufacturing.
Preferred Qualifications:
· In depth experience with chromatography operations at pilot or manufacturing scale, including column packing, process validation, and troubleshooting operational issues.
· An understanding of bioprocess economics, as well as strong knowledge of scale-up and scale-down sizing principles.
· A sound knowledge of process engineering fundamentals, especially fluid dynamics.
· Ability to communicate technical concepts to colleagues and clients using excellent written and verbal communication skills.
· Dependable, self-motivated, and able to thrive in an autonomous working environment.
Pay Range: $85,300- $187,700
Our ranges incorporate all levels and career types available within this specific role, and are derived from relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors. This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
$85.3k-187.7k yearly 21d ago
Associate Director, Global Medical Information and Review
Sarepta Therapeutics 4.8
Cambridge, MA job
Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits, see our website: *******************************
The Importance of the Role
The responsible individual will play a critical role in supporting, leading and development of the department of Medical Information & Review within the Medical Affairs function reporting to the Head of Global Medical Information & Review. This individual will work closely and effectively with key members of internal departments including Marketing, Legal/Compliance, Regulatory, PV, Medical Affairs and Clinical Development to assure that all materials, both promotional and medical, meet the rigorous standards of scientific accuracy, objectivity, and fair balance. This person will also serve on cross functional teams, representing medical affairs.
The Opportunity to Make a Difference
Develop and implement global medical information strategies aligned with biotech innovation and patient-centric values.
Create and maintain scientifically rigorous Standard Response documents based on emerging data and publications.
Manage external vendors and call center operations to ensure high-quality, timely responses to inquiries from healthcare professionals and patients
Serve as a key member of MRC & PRC review committees
Provide timely, medically relevant, scientifically sound, and fair-balanced medical/scientific reviews of materials submitted to medical and promotional reviews
Responsible for providing oversight of the review of promotional and medical materials for scientific/medical validity across Sarepta's Portfolio.
Represent medical affairs in global cross-functional team meetings
Critically review and provide solutions to complex promotional and medical pieces to ensure balance of the messages, medical accuracy, and appropriateness of the content of the materials/activities in accordance to scientific communication and with relevant guidance across Sarepta.
Proactively cultivate and grow strong relationships with cross-functional leads and other stakeholders to provide medical guidance in the development of scientific materials and resolve issues or concerns in promotional and medical review
Leverage defined metrics and other tools to improve team performance and ensure adequate resource allocation
Determine acceptability of data/references used to support promotional claims and provide expert guidance as well as effective negotiation leading to resolution for approval of pieces
Address any scientific decision support needs from inquiries coming into Sarepta.
Maintains in-depth understanding of the disease state, product, competitors, marketplace, related medical areas, and regulatory guidelines
Participate in the creation of, and ensure adherence to, departmental and corporate policies and SOPs and constantly look for places where process improvements would enhance the workflow
Support commercial planning and launch planning activities including training materials, and medical information to provide scientific and medical support for publications and presentations
Monitor the medical literature for Sarepta product(s) and relevant competitor data; analyzes the information for accuracy and relevance and appropriately synthesizes the data for inclusion in materials under review.
Collaborate with commercial operations, marketing, and regulatory operations to support the creation and submission of marketing materials and documentation to regulatory agencies
Collaborate with Global Medical Communications and Medical Information to align with scientific information, establishing consistent communication
Assist in driving consistency in medical information and communications, establishing one medical voice internally and externally
Participate in internal and external meetings (training, educational and others, including medical congresses) to remain current on ever changing regulations, relevant new medical/scientific information and commercial strategy
More about You
Advanced clinical/scientific degree: PharmD, PhD with 3 to 5 years of experience in medical affairs
Scientific expertise in rare disease and gene therapy a plus
Prior knowledge of the medical information and review process
Excellent interpersonal, written, and verbal communications skills are essential to establish cross functional relationships.
High degree of accuracy; eye for detail, fastidious
Ability to effectively manage time while balancing numerous high priority projects with a sense of urgency
Must be a strong team player and be willing to work in an environment where individual initiative and accountability to the team are required
Self-motivated with exceptional follow through
Demonstrates flexibility in response to changing needs and competing demands
Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion.
What Now?
We're always looking for solution-oriented, critical thinkers.
So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
#LI-Hybrid#LI-CM1This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.The targeted salary range for this position is $156,000 - $195,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.Candidates must be authorized to work in the U.S.Sarepta Therapeutics offers a competitive compensation and benefit package.Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
$156k-195k yearly Auto-Apply 33d ago
Talent Acquisition Coordinator (Contract)
Foundation Medicine 4.8
Foundation Medicine job in Boston, MA
About the Job
The Talent Acquisition Coordinator works closely with the Talent Acquisition team, hiring managers and candidates and is an integral part of the candidate experience for all potential new employees of Foundation Medicine. The TA Coordinator is responsible for coordination and scheduling of all interviews and serves as the main greeter of candidates during interviews.
Key Responsibilities
Provide operational support to the Talent Acquisition department with the primary area of focus on supporting the Talent Acquisition/Recruiting function.
Complete face-to-face and phone interview scheduling for all divisions.
Send general correspondence to candidates.
Coordinate travel arrangements for candidates.
Enter confidential data related to candidates and requisitions in the Applicant Tracking System (ORC).
Assist with welcoming candidates and preparation of conference rooms.
Assist with project work supporting TA Reporting, Campus Recruiting, Employer Branding and Executive Search.
Other duties as assigned.
Qualifications:
Basic Qualifications:
High School Diploma
Proficiency in Microsoft Office Suite
Preferred Qualifications:
Experience working with an Applicant Tracking System
Prior experience with travel coordination and calendar management
Ability to work in a fast-paced and changing environment
Strong organizational skills and excellent attention to detail
Excellent customer service skills with both internal and external customers
Understanding of HIPAA and importance of privacy of patient data
Commitment to reflect Foundation Medicine's values: Integrity, Courage, Passion
#LI-Hybrid
$47k-56k yearly est. Auto-Apply 12d ago
Sr. Oncology Sales Representative - Pittsburgh, PA
Merck 4.6
Boston, MA job
Our Sales team support our customers by providing clinical information about products, educational information, clinical training programs and resources. We support healthcare providers and healthcare systems meet the goals of the patients in their communities.
Our Company's Oncology organization is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of dauntless, forward-thinking individuals achieves this through an unwavering commitment to supporting accessibility to medicine, providing new therapeutic procedures, and collaborating with governments and payers to ensure that people who need medicines have access to them. At our company, our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe. As we continue to grow and define the Oncology market of the future, we are looking for dynamic, entrepreneurial individuals who thrive in a team environment and are driven to succeed.
The Oncology Sales Specialist is a key member of our customer facing organization and is responsible for partnering with customers to address identified needs, educating key stakeholders about our leading immunotherapy compound, and communicating our vision to the larger Oncology community.
+ This is a field-based sales position that will cover the **Pittsburgh, Pennsylvania territory** .
+ The selected candidate must reside within the territory.
+ Overnight travel may be required about 25% of the time.
+ Travel (%) varies based on candidate's location within the geography.
**General Responsibilities:**
+ Demonstrate in-depth knowledge of how to create a compelling and logical rationale for the value of products and how to contrast, compare, and position our company brand(s) versus competition using appropriate resources in informed discussions about products with HCP customers - knowing when/how to seek and provide additional information
+ Act as primary point of contact for customer. Meet with key customers/personnel to understand practice structure, business model, and key influencers.
+ Possess knowledge of cancer staging and possible treatment options and dosing schedules associated with different tumors/diseases, with comprehensive understanding of the impact of those options on the patient. Must understand impact and use of clinical trials in multiple tumor types/therapies, both in impact on promoted products and in practice behavior of the account.
+ Ability to analyze and identify trends in a complex buying environment. This includes the multiple channels of drug distribution, Oncology GPO's, wholesalers and specialty pharmacies. Review and evaluate patterns for products purchased and prescribed, outpatient vs in-patient infusion, as part of hospital contract, etc.
+ Demonstrate ability to understand complex account interdependencies in order to develop both short- and long-term account plans in conjunction with a wide array of stakeholders, proactively working with the account team and supervisor (known as the Customer Team Leader) to effectively execute the account plan. Share learnings and best-practices from one customer to help other customers meet their needs.
+ Influence beyond their specific geography or product area demonstrate advanced ability to ask strategic, insightful questions to obtain information on customer needs from all stakeholders in oncology accounts, using the insights to position our company Oncology brands and collaborate with customers on a customized strategy.
+ Collaborate and communicate effectively with extended "in-scope" customer team to ensure a consistent customer experience across our company's divisions and functional areas; ensure integration with the Key Account Manager, Nurse Educator, Field Reimbursement Associate, Medicare Account Executive, and other key stakeholders to share key customer learnings and support customer needs.
**Position Qualifications** **:**
**Minimum Requirements:**
+ Bachelor's degree with 6-8 years Sales experience OR a minimum of high school diploma with at least 10 years of equivalent experience
+ Equivalent experience can be: Professional sales experience, work experience in the healthcare/scientific field (including pharmaceutical, biotech, or medical devices) that is not sales related, professional marketing experience, or military experience
+ 2+ years of oncology field sales experience
+ Valid driver's license and ability to drive a motor vehicle
+ Travel the amount of time the role requires
**Preferred Experience and Skills:**
+ Documented history of strong performance in a sales / marketing or oncology clinical role
+ Clinical oncology experience across multiple solid tumors (Women's cancer - Breast, Ovarian, and Cervical)
+ Candidates with 0 - 2 years of oncology field sales experience will be hired at the S2 Oncology Sales Representative level.
+ Candidates with 2+ years of oncology field sales experience will be hired at the S3 Oncology Sales Specialist level.
MSJR
**Required Skills:**
Account Management, Account Management, Account Planning, Adaptability, Biodesign, Biopharmaceutical Industry, Cancer Diagnosis, Clinical Experience, Customer-Focused, Customer Handling, Customer Relationship Management (CRM), Customer Service, Digital Analytics, Healthcare Innovation, Healthcare Sales, Interpersonal Relationships, IS Audit, Lead Generation, Lead Generation Management, Market Analysis, Medical Devices, Oncology Sales, Pharmacology, Product Knowledge, Proven Commitment {+ 5 more}
**Preferred Skills:**
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$153,800.00 - $242,200.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** .
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
25%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
Yes
**Hazardous Material(s):**
N/A
**Job Posting End Date:**
01/3/2026
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R378747
$153.8k-242.2k yearly 9d ago
Validation Engineer 2 - R&D
Merck 4.6
Bedford, MA job
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
MilliporeSigma in Bedford, MA is hiring a Validation Engineer 2. As a member of the R&D Validation & Applications Center (VAC) Engineering team, you will actively participate on filtration product development teams to understand the new product and its applications. Your contribution includes development and implementation of an efficient and thorough validation test strategy which ensures robust product performance specifications based on product design and intended applications.
Responsibilities:
Authoring the validation test protocol, managing lab test requests, test execution, data analysis and authoring the report
Participate in process and product development supporting DOE studies and data analyses and creation of the product design specifications and risk assessments
Collaborate with Operations, Product Management, and Field Marketing to aid in product/process change requests, raw material qualifications, and customer applications
Hands-on design and development of new test methods, test equipment, and measurement systems which are utilized to characterize and validate new products, including troubleshooting, repairs, and identifying and implementing equipment upgrades/new technology and planning, documenting, and executing test method validations
Effectively interact with other groups, such as R&D development teams, Quality, Manufacturing, Engineering Services, Facilities, EHS, and Finance.
This position may include occasional travel to our manufacturing facilities
Who You Are
Minimum Qualifications:
Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or other Engineering field with 4+ years of experience in process development/validation
-OR-
Master's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or other Engineering field with 3+ years of experience in process development/validation
3+ years of experience with FMEA/risk analysis, product failure and root cause analysis
3+ years of experience with process and product/system validations (IQ/OQ/PQ), authoring formal protocols and reports utilizing Good Documentation Practice (GDP)
Preferred Qualifications:
Experienced with Product Development Process (PDP) and working on cross functional teams
Experience using statistical tools such as Capability, Gage R&R, DOE in Minitab
Capable in the development and execution of test method validations
Working knowledge of quality principles including ISO, Quality Management Systems, Good Documentation Practices
Knowledge of applicable FDA Regulations, USP requirements, Regulatory requirements (CB Scheme/ UL testing) for systems used in biopharmaceutical processes
Proficiency in equipment calibration, trouble shooting and repairs
Familiarity with change control methodology
Experience with MilliporeSigma filtration and chromatography products
Pay Range for this position: $80,400 - $140,300
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
$80.4k-140.3k yearly 48d ago
Software Engineer II
Foundation Medicine 4.8
Foundation Medicine job in Boston, MA
About the Job
The Software Engineer II, Computational Biology (WebApps Team) primarily develops web applications and rest endpoints that organize and display data from a highly concurrent, data-intensive pipeline infrastructure. This position completes design, development, unit testing, code reviews and technical documentation.
Code created in this position is to be reusable, testable, efficient, clean and well commented. This full stack engineer fully understands the web applications and services space, makes well-reasoned decisions, well-reasoned trade-offs, and is able to work in other parts of the codebase with guidance.
Key Responsibilities
Help define and participate in software development processes that leverages best practice and supports continuous product delivery.
Create custom programs and applications as designated by business need.
Write, test, and refactor code that is reusable, testable, efficient, well architected, and well commented.
Define and document architecture and formal technical specifications based upon information provided.
Maintain efforts for product or platform to be resilient, cloud-native, secure, and scalable.
Collaborate with team members to deliver complex production-ready projects.
Ensure code adheres to patterns and any established standards.
Participate in regular peer design and code reviews.
Conform to coding conventions and all aspects of the software development life cycle.
Deliver contributions in an Agile approach and leveraging Agile methodology.
Other duties as assigned.
Qualifications:
Basic Qualifications:
Bachelor's Degree
2+ years of Software Engineering experience
Preferred Qualifications:
Proficiency in Java and JavaScript
Java Spring, Hibernate, Maven, or similar frameworks
React, or similar UI framework
AWS or similar cloud computing platform
Unit and Integration testing
Git, or another version control system
Relational databases, database design, object-relational mapping (ORM)
SQL and query tuning
Knowledgeable about Unix or Unix-like operating systems
Enterprise distributed messaging systems
Genomics domain experience
Familiarity with continuous integration, continuous deployment, and Agile concepts
Understanding of HIPAA, the importance of patient data privacy, and of regulated software engineering environments
Commitment to reflect Foundation Medicine's values: Integrity, Courage, Passion
The expected salary range for this position based on the primary location of Boston, MA is $114,080 - $140,000 per year. The salary range is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.
#LI-Hybrid
$114.1k-140k yearly Auto-Apply 12d ago
Sr. Supply Chain Analyst
Foundation Medicine 4.8
Foundation Medicine job in Boston, MA
About the Job
The Senior Supply Chain Analyst is a proactive and detail oriented professional. They are responsible for optimizing and improving efficiency across the global supply chain process. The role will lead the analysis of complex and high-impact data related to strategic supply chain processes, design and generate performance reports, and provide strategic recommendations to support functional leadership decision-making. This role will drive collaboration with cross-functional stakeholders and senior leaders establishing processes with a strong emphasis on customer satisfaction, compliance, and governance modeling of our overall end-to-end improvements.
Key Responsibilities
Team Delivery
Drive and govern major initiatives to minimize systemic waste, reduce costs, and shorten cycle times across the end-to-end supply chain
Serve as a strategic liaison with stakeholder teams to translate business needs into long-range supply chain strategy
Design and execute complex, long-range scenario analyses to assess the strategic impact on production, inventory, and distribution plans
Establish, standardize, and strategically monitor key performance indicators (KPIs) across the entire process, ensuring organizational alignment
Customer-Excellence Focus
Lead the analysis of complex, enterprise-wide data related to supply chain processes and deliver insights and strategic recommendations to support senior leadership decision-making
Support Voice of Customer (VoC) feedback loops and translate input into actionable improvement projects
Influence and communicate effectively with external stakeholders, acting as the primary point of contact, where applicable, for strategic supply chain flow and issues
Lead the communication and execution of major change orders using the global change management process, driving the implementation of approved actions where applicable
Proactively assess and mitigate strategic, high-impact risks within the supply chain
Support data analysis of vendor performance and supplier management where applicable
Quality & Compliance
Draft, revise, and maintain department SOPs and Work Instructions to ensure regulatory and quality compliance
Collaborate with Quality and Regulatory teams during audits and inspections as a representative of the Supply Chain function
Own or support Corrective and Preventive Action (CAPA) initiatives related to supply chain activities
Other
Perform other duties as assigned.
Qualifications:
Basic Qualifications:
Bachelor's Degree in IT, business, computer science, or healthcare field
Or commensurate experience
5+ years of experience in an analytical, business intelligence, or operations related role
Preferred Qualifications:
Master's degree or relevant professional certifications are often preferred
Demonstrated experience leading and independently managing complex projects, analyses, or initiatives
Deep domain knowledge in the industry or function relevant to the role
Expert skills in Microsoft excel and proficiency in business intelligence (Tableau, PowerBI)
Data querying and management, with proficiency in writing complex queries and managing data
Excellent written and verbal communication skills to translate complex data and technical findings into clear, actionable recommendations for senior leadership and non-technical stakeholders
Willingness to roll up sleeves and execute operational tasks while leading initiatives
Ability to mentor or guide junior analysts, provide feedback, and lead a small team or project group
Superior problem-solving and critical thinking skills to investigate business problems and model solutions holistically
Experience with project management, scoping projects, and managing timelines
Proven track record of supporting change management, influencing change, process improvements, and scaling operations for growth
Experience managing global value add activities, including suppliers and logistics across regions
Strong alignment with company's purpose, values and mission, and history of inspiring this in one's own team
Understanding of HIPPA and importance of patient data privacy
Commitment to reflect Foundation Medicine's values: Integrity, Courage, Passion
Ability to travel up to 20% to all US and ex-US lab sites, if business need is presented
The expected salary range for this position based on the primary location of Boston, MA is $93,500 - $116,900 per year. The salary range is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.
#LI-Hybrid
Be a part of the legacy: Postdoctoral Research Fellow Program Our Research Laboratories' Postdoctoral Research Fellow Program aims to be a best-in-industry program for industrial postdoctoral researchers, designed to provide you with an academic focus in a commercial environment. With the resources, reach, and expertise of a large pharmaceutical company, postdoctoral researchers will be positioned to excel in an institution committed to breakthrough innovation in research and discovery.
The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) function at research laboratories is seeking a highly motivated postdoctoral fellow with expertise in machine learning to help transform drug discovery and preclinical development. You will join an interdisciplinary team and collaborate closely with research partners across our global organization. You will invent, prototype, and apply advanced Machine Learning (ML) methods-particularly in generative modeling and related areas-to expand our capabilities in designing, prioritizing, and characterizing novel therapeutic candidates.
Primary Responsibilities
+ Conduct original research to develop state-of-the-art AI/Machine learning methods for drug discovery (e.g., molecular generative models, multi-objective optimization, property prediction, active learning, document authoring, document generation, hybrid AI system, multi-agent system)
+ Design and execute experiments, analyze results rigorously, and iterate rapidly on model architectures and training strategies
+ Build robust, reproducible code and workflows; contribute to shared libraries and documentation
+ Collaborate with chemists, biologists, Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) scientists, and data/ML engineers to translate methods into impactful applications
+ Communicate findings through internal presentations and peer-reviewed publications; present at conferences and workshops
**Education Minimum Requirements**
+ Ph.D. (or completion within six months) in Computer Science, Statistics, Physics, Applied Mathematics, Bioinformatics, Computational Biology, Chem/Informatics, Engineering, or a related field
**Required Experience and Skills**
+ Demonstrated research excellence and problem-solving ability; strong motivation to learn, innovate, and deliver
+ Proficiency in core ML/statistics topics such as probability, statistical inference, optimization, discrete math/algorithms, and/or probabilistic modeling
+ Strong programming skills in Python and experience with modern ML frameworks (e.g., PyTorch, TensorFlow)
+ Track record of publications and/or presentations in ML, computational chemistry/biology, or related fields
+ Excellent collaboration and communication skills; proven ability to work in cross-functional teams
**Preferred Experience and Skills (nice to have)**
+ Experience with molecular representations (e.g., SMILES, graphs), generative models (e.g., diffusion models, VAEs, flow models), and sequence/structure models (e.g., transformers, GNNs, protein or RNA models)
+ Familiarity with cheminformatics/biophysics toolkits (e.g., RDKit), docking or molecular simulation, ADMET modeling, or DMPK-relevant endpoints
+ Practical experience with experimental design, active learning, uncertainty quantification, or multi-objective optimization
+ Software engineering best practices (Git, testing, containers), and experience working with large datasets and cloud/GPU environment postdoctoralopportunities
**Required Skills:**
Accountability, ADME, Clinical Study Management, Dosage Forms, Drug Metabolism, Ethical Compliance, Innovation, Machine Learning (ML), Modeling Simulations, Personal Initiative, Pharmaceutical Analysis, Pharmacodynamics, Pharmacognosy, Pharmacokinetic Modeling, Pharmacokinetics, Protocol Development, Regulatory Submissions, Scientific Writing
**Preferred Skills:**
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$70,500.00 - $110,900.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** .
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
Domestic
**VISA Sponsorship:**
Yes
**Travel Requirements:**
10%
**Flexible Work Arrangements:**
Not Applicable
**Shift:**
Not Indicated
**Valid Driving License:**
No
**Hazardous Material(s):**
n/a
**Job Posting End Date:**
01/17/2026
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R378049
$70.5k-110.9k yearly 9d ago
Engineer 2 - Product Development
Merck 4.6
Bedford, MA job
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
MilliporeSigma in Bedford, MA is seeking a Product Development Engineer to design, develop, and test novel filtration devices suitable for the manufacture of therapeutic biopharmaceuticals.
The Product Development Engineer 2 within the Aseptic Filtration group of Filtration R&D Department is responsible for the development of novel filtration products/technologies that enable the future manufacturing of therapeutic biopharmaceuticals.
Responsibilities:
Support technology and product development projects to deliver future filtration technologies for a wide range of bioprocessing applications
Activities may include designing the filtration devices and components, analyzing the problem, evaluating novel technologies/concepts/equipment, conceptualizing a technical path forward, technology transfer to our manufacturing plants
Apply solid scientific and engineering principles as well as institutional knowledge to solve complex scientific and engineering problems
Work collaboratively with both internal and external support functions to obtain project objectives
Utilize independent thinking to achieve project goals
This position may include domestic travel (10-30%)
Who You Are:
Minimum Qualifications:
Bachelor's degree in Mechanical Engineering, Plastics Engineering, Applied Science, Physics or other Science or Engineering field with 3+ years of experience in structure design
OR
Master's degree in Mechanical Engineering, Plastics Engineering, Applied Science, Physics or other Science or Engineering field with 2+ years of experience in structure design
2+ years of experience in 3D CAD modeling software (Solidworks, Creo, AutoCAD, etc.)
2+ years of experience designing complex components, assemblies and systems to ensure high-quality construction and functionality
Preferred Qualifications:
Proficient in design of experiments (DOE) and statistical analysis methods
Design experience with plastic materials and injection molding
Demonstrated strong fundamental understanding of science/engineering principles related to filtration
Experience in utilizing a variety of prototyping techniques, including machining, 3D printing, sheet metal fabrication etc. to manufacture components
Develop and clearly communicate innovative product designs, applications, technologies, or concepts to project team and R&D management and customers as needed
Experience in Finite Element Analysis (FEA), Computational Fluid Dynamics (CFD), and/or Injection molding simulation
Fluent in Microsoft Office Suite (Word, Excel, PowerPoint, Project) and statistical analysis software such as Minitab or JMP
Track record of innovation and success in product design/development projects
Sense of urgency and unwavering resolve to meet project timelines and customer needs
Pay Range for this position: $80,400 - $140,300
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
$80.4k-140.3k yearly 49d ago
Dir, BioPharma Strategic Transactions
Foundation Medicine 4.8
Foundation Medicine job in Boston, MA
About the Job
The Director, BioPharma Strategic Transactions is a key member of the BioPharma Team and Head of the Transaction Excellence team. This position works collaboratively across BioPharma and as part of the BEP and BPD teams. This position works with external partners to drive innovation in and guidance for deals that can support growth in more complex, solution-based or end-to-end partnerships.
Key Responsibilities
Provide strategic leadership on the development and structuring of novel, complex, end-to-end solutions-based deals.
Manage the Transaction Excellence team of business development managers to identify needs and opportunities to evolve our deal structure for strategic partnerships and new business.
Lead the development and delivery of guidance that can support value creation and deal processes that streamline and expedite time from opportunity to deal execution.
Work closely with legal, compliance and others as needed to develop deal templates that can be leveraged by partner-facing teams.
Act as internal thought partner for externally-facing deal team members and ensure consistency in approaches across partners by training and provision of expertise.
Support the development of overarching BioPharma transaction strategy.
Maintain availability to work outside of a regularly scheduled shift.
Travel domestically and internationally up to 20% of the time.
Lead/support other projects as periodically assigned.
Qualifications:
Basic Qualifications:
Advanced degree in business or a scientific discipline
10+ years business development, alliance management experience in a diagnostic company with a focus in Oncology
Preferred Qualifications:
Significant experience partnering with biopharmaceutical companies, contract negotiation and deal execution
Experience leading and working collaboratively in multi-disciplinary teams, across multiple functional areas and development phases
Experience working in dynamic teams; demonstrated ability to operate and deliver in a fast pace environment and with ambiguity
Good knowledge of global oncology therapeutics, biomarker & genomics markets
Strong communication skills and ability to present effectively across a range of stakeholders
Understanding of HIPAA and importance of privacy of patient data
Commitment to reflect Foundation Medicine's values: Integrity, Courage, Passion
The expected salary range for this position based on the primary location of Remote is $179,040 - $223,800 per year. The salary range is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.
#LI-Hybrid
Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits, see our website: *******************************
The Importance of the Role
The Senior Manager of Cost Accounting and Manufacturing Operations will be responsible for managing the execution of processes aimed at delivering performance-based analytics within the Technical Operations organization. Key duties include managing the product costing process to support strategic business planning, standard costing, and the annual business planning cycle. Collaborating closely with FP&A and the Director of Inventory and Manufacturing, this role will drive the creation and deployment of a financial analytical framework for the Technical Operations Organization. Additionally, this position will supervise a costing group and oversee all financial aspects related to inventory and manufacturing operations for both commercial and clinical programs, including cost accounting. This position will also manage financial accounting processes, policies, procedures, and internal controls within these areas, working closely with Technical Operations and FP&A team members to assist in forecasting and budgeting. The position will also be tasked with managing the accounting related to these areas and the financial reporting.
The Opportunity to Make a Difference
Developing a strong business partner relationship with the Manufacturing, QA, QC, and Process Development functions.
Managing a financial performance management platform for the Technical Operations Organization
Manage Inventory and Manufacturing Finance Costing Team.
Manage and complete the monthly accounting close process related to inventory, manufacturing, and clinical trials, ensure compliance with U.S. GAAP.
Analyze and validate all inventory transactions in Oracle.
Develop, implement, and maintain a standard cost accounting process for our manufacturing operation, including performing periodic cost studies in support of our standard cost model and the regular investigation, resolution and reporting of actual-to-standard variances.
Work directly with Third Party vendors to ensure accurate monthly reports.
Develop and maintain inventory cycle counting process.
Provide business analysis, forecasting and budgeting with the Technical Operations organization in partnership with our FP&A group, including making recommendations for financial and operational improvements.
Maintain and make recommendations to improve our system of internal accounting controls as they relate to inventory and manufacturing.
Work within our existing Oracle ERP system and the Oracle Process Manufacturing module, lead efforts to recommend and implement any expansions of this system.
Manage the preparation of the internal and external reporting related to these key areas, including internal monthly reporting and quarterly reporting to be filed with the SEC and assist in the external audit functions.
Develop monthly inventory reports for Finance leadership and business partners to support analytics and strategic decision making.
Develop monthly flux analytics to support SEC filings.
More about You
Bachelor's and/or master's degree in accounting/finance or similar.
Seven to Nine years' experience in manufacturing, inventory/finance positions of growing responsibilities
Requires a strong working knowledge of Oracle OPM Financials module.
Solid understanding of manufacturing operations, inventory, and cost accounting.
Understanding of U.S. GAAP as it applies to a manufacturing environment is required.
Knowledge of accounting statements and financial reporting experience in biotechnology and/or pharmaceuticals strongly encouraged.
Excellent analytic skills; highly proficient in Excel-based modeling with strong computer skills are also required.
Excellent organizational and project management skills, ability to prioritize appropriately and meet deadlines.
Strong communication and interpersonal skills, able to work effectively with personnel throughout the company as well as external vendors.
Strong managerial skills with the ability to motivate and mentor staff.
Strong understanding of SOX controls, design and implementation and ongoing evaluation of controls.
What Now?
We're always looking for solution-oriented, critical thinkers.
So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
#LI-Hybrid#LI-ES1This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.The targeted salary range for this position is $132,000 - $165,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.Candidates must be authorized to work in the U.S.Sarepta Therapeutics offers a competitive compensation and benefit package.Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
$132k-165k yearly Auto-Apply 60d+ ago
Scientific Director, Pharmacometrics
Merck 4.6
Billerica, MA job
Work Your Magic with us! Start your next chapter and join EMD Serono.
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Your Role:
The role of Scientific Director, Pharmacometrics, in Quantitative Pharmacology within the broader Clinical Measurement Sciences organization, is a scientific and cross-functional role, responsible for developing and executing Model Informed Drug Development (MIDD) plans and strategies from the early translational to the late-stage clinical development in cross functional drug discovery and development project teams in close collaboration with colleagues in Clinical Pharmacology, Translational Quantitative Pharmacology, Biostatistics, Data Sciences, Patient-Focused Real-World Evidence, Clinical Biomarkers and Diagnostics, Research, Clinical Development and other colleagues within the R&D organization.
In this role, the incumbent will participate in activities to strengthen pharmacometrics platform capabilities by contributing to the strategic use of modeling & simulation (M&S) methodologies across disease areas, in alignment with the clinical development plan. There will be close engagement with all key stakeholders to ensure timely and high-quality pharmacometrics deliverables for the program.
The incumbent will be responsible for pharmacometrics activities executed internally or in collaboration with external CROs and will provide close scientific and technical supervision. The incumbent will also be expected to independently manage multiple projects simultaneously and participate in discussions and presentations.
This position reports to the Global Head of Pharmacometrics and Systems Pharmacology.
Key Accountabilities:
Prepare, execute, present, report and/or supervise modeling & simulation projects; responsible for summarizing and reporting pharmacometrics content in relevant regulatory submission documents (e.g., HA Briefing Documents, CTD 2.7.2)
Develop and execute MIDD strategies/plans which are fully integrated with the overall clinical development plan
Apply MIDD methodologies to contribute to decision making at critical milestones based on quantitative principles in close collaboration with partner functions
Practice and promote quantitative decision-making by leveraging the totality of evidence approach and enable the integration of all relevant data within and outside the development program (including literature and competitor data, and Real World data) using state-of-the-art disease models, clinical trial simulations and Bayesian probabilistic frameworks to enhance clinical trial design and inform assessment of probability of success
Collaborate with Translational QP to appropriately transition Quantitative Systems Pharmacology models developed in Research and preclinical development to population PK/PD M&S frameworks that preserve adequate mechanistic resolution for applications in clinical development.
Keep up to date with scientific advancements in pharmacometrics and share expertise with colleagues.
Who You Are:
Minimum Qualifications:
PhD in Pharmacometrics or a related disciple (e.g. Clinical Pharmacology, Statistics, Engineering, Mathematics)
5+ years of experience with hands-on pharmacometrics modeling and application of MIDD principles in a drug-development setting.
Position requires both domestic and international travel up to 20% of time
Preferred Qualifications:
Excellent knowledge of and experience in application of population PK/PD models, exposure-response models, disease progression models, clinical trial simulations, Bayesian methodologies, and model-based meta-analyses to drive MIDD
Thorough understanding of global regulatory guidelines relevant to MIDD (e.g., Population PK, exposure-response, pediatric extrapolation)
Ability to translate highly mechanistic systems models to population PK/PD frameworks in clinical development
Experience in pharmacostatistical modeling methods and sound understanding of the principles of statistics including Bayesian methodologies as applicable for advanced pharmacometrics modeling and clinical trial simulations
Knowledge of emerging areas of pharmacometrics including applications of machine learning/ artificial intelligence for model-informed precision medicine development
Experience with model-informed development of both small molecules and biologics and across all phases of clinical development is required.
Good command of NONMEM and R is an absolute prerequisite. Experience with other tools (e.g., MONOLIX, PsN, Xpose, SAS, Stan, Python, MATLAB and Simcyp) is desired.
General knowledge of oncology, neurology and/or immunology, is desirable
Pay Range for this position: $185,600 - 278,300
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other prequisites. For more information click here.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
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