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When you join Virginia Mason Franciscan Health, you become part of a team that delivers top-quality, professional healthcare in modern, well-equipped facilities, and contributes to a legacy of service built on collaboration and shared purpose. Our comprehensive network of 10 hospitals and nearly 300 care sites strategically located across the greater Puget Sound region reflects our ongoing commitment to accessibility and comprehensive care.

HOUR

**Job Summary and Responsibilities**

As our Medical Lab Scientist, you will be a critical diagnostic expert, performing complex laboratory tests to ensure accurate, timely results vital for patient diagnosis and treatment.

Every day, you will execute a wide range of analytical procedures across various lab disciplines (hematology, chemistry, microbiology, etc.). You'll analyze specimens, operate/maintain instruments, interpret results, and conduct quality control, providing crucial data for clinical decisions.

To be successful in this role, you must demonstrate a strong scientific foundation, advanced technical proficiency, exceptional problem-solving skills, and meticulous attention to detail. Your paramount commitment will be to accuracy and regulatory adherence.

+ Performs and reports waived, moderately complex, and highly complex test procedures on patient specimens adhering to the Section's Standard Operating Procedures to ensure accurate and timely reporting

+ Provides excellent patient care through clinical correlation of results, identification of patterns of bias, rapid notification of appropriate caregivers of critical values, and completion of testing within established turn-around-time limits

+ Ensures that major automated equipment is operational by performing required maintenance, calibration and troubleshooting procedures; including contacting of instrument vendor for assistance or repair

+ Performs required calibration and quality control procedures and maintains records to ensure tests are being performed within established parameters

+ Performs proficiency testing as assigned and review results with laboratory clinical leaders

+ Assists in evaluation and generation of compliant documentation for the validation of new procedures and equipment to provide the physician with the most current laboratory technology

**Job Requirements**

Required

+ Bachelors Of Science in a biological or chemical science as defined by CLIA., upon hire

Preferred

+ International Medical Laboratory Scientist, upon hire or

+ Blood Banking, upon hire or

+ Chemistry - ASCP, upon hire or

+ Clinical Laboratory Scientist, upon hire or

+ Clinical Laboratory Technologist, upon hire or

+ Technologist in Molecular Biology, upon hire or

+ Medical Laboratory Scientist - Med Technologist, upon hire or

+ Medical Technologist AAB, upon hire or

+ Technologist in Microbiology, upon hire or

+ Medical Technologist AMT, upon hire or

+ Specialist in Hematology, upon hire or

+ Specialist in Microbiobiology, upon hire or

+ Med Technologist - ASCP, upon hire or

+ Histotechnologist, upon hire

Where You'll Work

Virginia Mason Franciscan Health has a rich history of providing exceptional healthcare, dating back to 1891. Building upon a legacy of compassionate care and innovation, our organization has evolved over the years through strategic partnerships and integrations to expand our reach and services across the Puget Sound area.

Today, as Virginia Mason Franciscan Health, we remain deeply committed to healing the whole person - body, mind, and spirit - in the communities we serve. This commitment is strengthened by the diverse expertise and shared values brought together through our growth.

Our dedicated providers offer a full spectrum of health care services, from routine wellness to complex disease management, all grounded in rigorous research and education. Our comprehensive network of 10 hospitals and nearly 300 care sites strategically located across the greater Puget Sound region reflects our ongoing commitment to accessibility and comprehensive care.

We are proud of our pioneering medical advances and numerous awards and accreditations that reflect our dedication to excellence. When you join Virginia Mason Franciscan Health, you become part of a team that delivers top-quality, professional healthcare in modern, well-equipped facilities, and contributes to a legacy of service built on collaboration and shared purpose.

**Pay Range**

$38.82 - $57.95 /hour

We are an equal opportunity/affirmative action employer.

Virginia Mason Franciscan Health

Medical Laboratory Scientist

Alliance/Partner Management

Analysis Skills

Biology

Blood Bank

Calibration

Chemistry

Clinical Data

Clinical Laboratory

Clinical Outcomes

Detail Oriented

Healthcare

Healthcare Quality

Hematology

Identify Issues

Laboratory Testing

Medical Diagnosis

Medical Treatment

Microbiology

Molecular Analysis

Molecular Biology

Patient Care

Problem Solving Skills

Quality Control

Record Keeping

Regulatory Compliance

Specimen Analysis

Standard Operating Procedures (SOP)

Testing

Time Management

Validation Documentation

monster

Position Summary** The Associate Director of MSAT (Manufacturing Science & Technology) - Analytical Sciences will serve as a scientific and technical leader supporting tech transfer, and commercial manufacturing of biologic drug substances and drug products. The ideal candidate brings deep expertise in biologics analytics, strong cross-functional leadership, and experience working with external contract manufacturing companies.

**Position Summary**

The Associate Director of MSAT (Manufacturing Science & Technology) - Analytical Sciences will serve as a scientific and technical leader supporting tech transfer, and commercial manufacturing of biologic drug substances and drug products. This role oversees analytical lifecycle management, method qualification/validation, comparability, control strategy implementation, and investigations. The ideal candidate brings deep expertise in biologics analytics, strong cross-functional leadership, and experience working with external contract manufacturing companies.

**Key Responsibilities**

+ Lead the analytical sciences function within MSAT to ensure robust support for commercial manufacturing of biologics (e.g., mAbs, fusion proteins).

+ Drive analytical control strategy, specification setting, and lifecycle management in alignment with QbD principles.

+ Oversee method performance monitoring and trending, analytical capability assessments, and continuous improvement initiatives.

+ Provide analytical subject matter expertise (SME) during technology transfers to external manufacturing sites.

+ Support manufacturing investigations by leading root-cause analyses, interpreting analytical data, and defining corrective and preventive actions.

+ Guide method troubleshooting, resolution of OOS/OOT trends, and process-product linkages (CQA-CPP relationships).

+ Lead analytical method qualification/validation strategy to meet Phase-appropriate and commercial requirements.

+ Author, review, and approve analytical sections of regulatory filings (BLA/MAA, responses to agency queries).

+ Partner with QA, Regulatory, and MSAT to ensure compliance with global regulatory guidelines (ICH Q2, Q6B, Q14, etc.).

+ Partner closely with Process Development, Quality Control, Quality Assurance, Regulatory teams.

+ Drive analytical readiness for tech transfers, PPQ readiness, comparability assessments, and lifecycle changes.

+ Lead external oversight of CDMOs/CROs, ensuring analytical deliverables, timelines, and quality expectations are met.

+ Ensure data integrity and proper scientific documentation across MSAT analytical activities.

**Qualifications**

**Required**

+ PhD or MS in Analytical Chemistry, Biochemistry, Molecular Biology, Chemical Engineering, or related field.

+ 8 + years (PhD) or 12+ years (MS) of experience in analytical development, QC, or MSAT for biologics.

+ Demonstrated technical expertise in analytical methods for biologics (e.g., HPLC/UPLC, CE, LC-MS, bioassays, ELISA, spectroscopy).

+ Strong experience in commercial biologics manufacturing support, tech transfer, and method lifecycle management.

+ Deep knowledge of global regulatory expectations for biologics (ICH Q5, Q6, Q8, Q14; FDA and EMA guidance's).

+ Proven leadership skills and experience managing teams or cross-functional technical groups.

+ Experience with commercial biologics PPQ and BLA/MAA submissions.

+ Expertise in statistical tools (e.g., JMP, Minitab) and digital data systems (e.g., LIMS)

+ Experience working with CDMOs/CROs and external manufacturing partners.

+ Strong understanding of CQAs, control strategy development, and analytical-process integration.

**Competencies**

**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.

**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.

**Empowered Development -** Play an active role in professional development as a business imperative.

Minimum $169,222.00 - Maximum $253,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

**Application Deadline** : This will be posted for a minimum of 5 business days.

**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka .

**Disclaimer:**

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .

**Statement Regarding Job Recruiting Fraud Scams**

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External .

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov , or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka 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.

Otsuka America Pharmaceutical Inc.

Associate Director, MSAT - Analytical Sciences (Biologics)

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Medical Laboratory Scientist Virginia Mason Franciscan Health

Associate Director, MSAT - Analytical Sciences (Biologics) Otsuka America Pharmaceutical Inc.

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