Be an early applicantLess than 25 applicants

Company

Original Job Post

BioSpace · 2 days ago

Manager, Lab Operations (Analytical Development)

Bridgewater, NJ

Full-time

Hybrid

Senior Level

$111K/yr - $156K/yr

10+ years exp

Wonder how qualified you are to the job?

Maximize your interview chances

BiotechnologyCommunities

Comp. & Benefits

Insider Connection @BioSpace

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Manages direct reports including project assignments, team role assignments, formal quarterly performance reviews, assisting with career development of direct reports, documenting operational tasks, and reporting to upper-level management.

Oversees all analytical development lab operations, including oversight of the maintenance and qualifications of all analytical instrumentation as well as approving and managing spend for lab consumable purchases. This will include authorship, review, and approval of technical documents such as qualification protocols and SOPs as well as the design and setup of new lab expansions.

Serves as the analytical development SME for internal and external cross-functional projects.

Communicates results of experiments and presents findings to cross-functional project teams.

Evaluates, designs, and performs method validation, employing phase-appropriate approaches at different stages including Commercial for assay, purity, identification of impurity and degradation products, reference standard qualification and physical (solid-state) characterization of drug product and drug substance.

Prepares and approves technical documents (analytical test methods, experimental plans, SOPs, method development reports, validation protocols and reports).

Serves as the analytical development business owner for computerized system. As the AD Business owner, responsibilities will include, but not be limited to, serving as the system administrator for analytical software such as Empower 3; review and approval of all documents; coordinating with appropriate IT groups to troubleshoot any issues that may arise.

Builds strong relationships with external vendors to learn and evaluate new and upcoming technologies, including scheduling lunch and learns.

Able to work in a fast-paced, team-oriented environment with accelerated timelines.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Analytical method developmentAqbd method developmentAnalytical characterizationDosage formsAnalytical instrumentationHplcUplcSecCadSemDissolutionGcKfSec-malsMsStatistical skillsGxpCmcIchRegulatory requirementsMicrosoft officeSystem administrationAnalytical softwareWaters empower 3Bmram r4Waters connectSiiThird party driversProblem-solvingCommunication

Required

B.S or M.S. in Chemistry, Biochemistry or related discipline with 10+ years of experience or PhD with 3+ years of experience in the pharmaceutical industry.

2+ years of experience managing direct reports including prior experience with training and mentoring other technical staff.

Expertise in analytical method development. Proficiency with AQbD method development is a plus.

Experienced in analytical characterization of multiple dosage forms including solid oral, liquid dosage, inhalation and combination products.

Experience with analytical instrumentation such as HPLC/UPLC, SEC, CAD, SEM, Dissolution, GC, and KF are a must. Experience with SEC-MALS and MS are a plus.

Strong statistical skills with a good understanding of basic and intermediate statistical tests.

Good understanding of GxP, CMC, ICH and compendial (USP/EP/JP) regulatory requirements.

Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

Proficient with System Administration of analytical software such as Waters Empower 3, BMRAM R4, and Waters Connect. Experience with third party drivers like SII for Empower is a plus.

Must have strong communication skills.

Highly organized with a strong attention to detail, clarity, accuracy and conciseness.

Must successfully exhibit Insmed's five (5) core values of Collaboration, Accountability, Passion, Respect, and Integrity along with any other position specific competencies.

Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.