myGwork - LGBTQ+ Business Community · 4 days ago

Product Manager

Massachusetts, United States

Full-time

Onsite

Senior Level

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Responsibilities

Work with hardware product managers to convert product needs into software requirements.

Lead cross-functional product development teams in aspects associated with product definition and product development.

Assess market trends and competition offerings to develop and implement proactive strategies to strengthen the product line's business advantage and build product requirements.

Maintain documentation per the new product development and introduction (NPDI) process, including product requirements, user stories for development, and intellectual property reviews.

Represent the product in presentations, publications, and customer labs worldwide.

Qualification

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LC-MS hardwareQuantitative software solutionsTriple QuadrupoleQ-TOFOrbitrap MS systemsMass spectrometry techniquesSmallLarge molecule analysisAnalytical techniquesSoftware development lifecycle (SDLC)Agile methodologiesRequirements gatheringSoftware testingQuality assurance processesLaboratory ExperienceGxP EnvironmentDocumentationRegulatory ComplianceBiotech IndustryBiopharmaceutical IndustryFDA Regulations21 CFR Part 11Analytical MethodsQualificationValidation

Required

BS Degree required.

Extensive experience with LC-MS hardware and accompanying quantitative software solutions is required with hands-on experience using Triple Quadrupole, Q-TOF, and/or Orbitrap MS systems being highly preferred.

Deep understanding of mass spectrometry techniques and their applications to both small and large molecule analysis, as well as other analytical techniques is desired.

Familiarity with the software development lifecycle (SDLC) is important to effectively lead the development of LC-MS quantitative software. Knowledge of agile methodologies, requirements gathering, software testing, and quality assurance processes is valuable.

Preferred

MS or Ph.D. preferred.

Laboratory experience with GxP environment, documentation and regulatory compliance in the biotech/biopharmaceutical industry is a plus. Familiarity with FDA regulations, such as 21 CFR Part 11, and other related industry standards is ideal.

Deep understanding of analytical methods qualification/validation also a plus.