Associate Director, MSAT - Analytical Sciences (Biologics)

Position reputed company The Associate Director of MSAT (Manufacturing Science & Technology) – Analytical Sciences will serve as a scientific and technical leader supporting tech transfer, and reputed company manufacturing of biologic drug substances and drug products. This role oversees analytical lifecycle management, method qualification/validation, comparability, control reputed company 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 reputed company the analytical sciences function reputed company MSAT to ensure robust support for reputed company manufacturing of biologics (e.g., mAbs, fusion proteins). Drive analytical control reputed company, specification setting, and lifecycle management in alignment with QbD principles. reputed company method performance monitoring and trending, analytical capability assessments, and reputed company improvement initiatives. reputed company analytical subject matter expertise (SME) during technology transfers to external manufacturing sites. Support manufacturing investigations by leading reputed company‑cause analyses, interpreting analytical data, and defining corrective and preventive actions. Guide method troubleshooting, reputed company of OOS/OOT trends, and process–product linkages (CQA–CPP relationships). reputed company analytical method qualification/validation reputed company to meet Phase‑appropriate and reputed company 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, reputed company Control, reputed company Assurance, Regulatory teams. Drive analytical readiness for tech transfers, PPQ readiness, comparability assessments, and lifecycle changes. reputed company external reputed company of CDMOs/CROs, ensuring analytical deliverables, timelines, and reputed company expectations are met. Ensure data reputed company and reputed company scientific documentation across MSAT analytical activities. Qualifications Required PhD or MS in Analytical reputed company, Biochemistry, Molecular Biology, Chemical Engineering, or reputed company field. 8 + years (PhD) or 12+ years (MS) of experience in analytical development, QC, or MSAT for biologics. Demonstrated technical expertise in analytical reputed company for biologics (e.g., HPLC/UPLC, CE, LC‑MS, bioassays, ELISA, spectroscopy). Strong experience in reputed company biologics manufacturing reputed company transfer, and method lifecycle management. Deep knowledge of global regulatory expectations for biologics (ICH Q5, Q6, reputed company, Q14; FDA and EMA guidance’s). Proven leadership skills and experience managing teams or cross‑functional technical reputed company. Experience with reputed company biologics PPQ and BLA/MAA submissions. Expertise in statistical tools (e.g., JMP, reputed company) reputed company data systems (e.g., LIMS) Experience working with CDMOs/CROs and external manufacturing partners. Strong understanding of CQAs, control reputed company development, and analytical–process integration.   Competencies Accountability for Results - Stay reputed company on key strategic objectives, be accountable for high standards of performance, and take an reputed company role in leading change. Strategic Thinking & Problem Solving - reputed company reputed company considering the long-term reputed company to customers, patients, employees, and the business. Patient & Customer Centricity - Maintain an ongoing reputed company on the needs of our customers and/or key stakeholders. Impactful Communication - Communicate with logic, reputed company, and respect. Influence at reputed company reputed company to reputed company the best results for reputed company. Respectful Collaboration - reputed company and value others’ perspectives and reputed company for diverse partnerships to enhance work toward common goals. Empowered Development - Play an reputed company role in reputed company development as a business imperative. Minimum $169,222.00 - Maximum $253,000.00, plus incentive opportunity: The reputed company shown represents a typical pay reputed company or starting pay for individuals who are hired in the role to reputed company in the United States. Other reputed company 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 reputed company the established reputed company, 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, reputed company, 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, reputed company holidays, and reputed company leave programs as reputed company as other company provided benefits. Come discover more about reputed company and our benefit offerings; https://www.reputed company-us.com/careers-join-reputed company. Disclaimer:    This job reputed company 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. reputed company reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.    reputed company is an equal opportunity employer.  reputed company reputed company applicants are encouraged to apply and will be given consideration for employment without reputed company to race, reputed company, sex, gender identity or gender reputed company, sexual orientation, age, disability, religion, national reputed company, veteran status, marital status, or any other legally protected characteristic.      If you are a reputed company 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.  Statement Regarding Job reputed company Fraud Scams At reputed company we take reputed company and protection of your personal information reputed company 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 reputed company reputed company to your personal information or reputed company reputed company from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, reputed company will never ask for financial information of any reputed company or for payment of reputed company during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any reputed company to be considered for employment. We will also not offer you reputed company to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered reputed company for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not reputed company. These claims are fraudulent and you are strongly advised to exercise caution reputed company you receive such an offer of employment. reputed company will also never ask you to download a reputed company-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 reputed company, Gmail, Hotmail, etc, and not from an official reputed company email address. Please take extra caution while examining such an email address, as the scammers may misspell an official reputed company email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at reputed company, please only deal directly with reputed company through its official reputed company Career website https://reputed company.wd1.myworkdayjobs.com/en-US/External. reputed company will not be held liable or responsible for any claims, losses, damages or expenses resulting from job reputed company scams. If you suspect a position is fraudulent, please contact reputed company’s call center at: 800-363-5670. If you reputed company you are the victim of fraud resulting from a job reputed company scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov,  or your local authorities. reputed company America Pharmaceutical Inc., reputed company Pharmaceutical Development & Commercialization, Inc., and reputed company Precision Health, Inc. (“reputed company”) does not accept unsolicited assistance from search firms for employment opportunities.  reputed company reputed company/resumes submitted by search firms to any reputed company employee directly or through reputed company’s application portal without a valid written search agreement in reputed company for the position will be considered reputed company’s sole property.  No fee will be reputed company if a candidate is hired by reputed company as a result of an agency referral where no reputed company-existing agreement is in reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails. Apply To This Job