Cmc Program Manager Jobs in Michigan (NOW HIRING)

Element Ann Arbor is currently seeking a highly experienced Principal Scientist – Bioseparation to lead and execute advanced analytical method development, characterization, and validation of large molecule therapeutics across discovery, development, and late-stage CMC. This is an onsite, laboratory-based role with significant hands-on responsibility in bioseparation sciences, supporting a broad range of biologics modalities including proteins and recombinant proteins, peptides and peptide-drug conjugates, monoclonal antibodies (mAbs) and biosimilars, antibody-drug conjugates (ADCs), mRNA therapeutics, DNA constructs (including plasmid DNA and oligonucleotides), viral vectors, and other complex or emerging modalities such as fusion proteins, multispecifics, and engineered biologics.

• Lead development, optimization, and troubleshooting of bioseparation-based analytical methods supporting biologics across discovery, development, and late-stage CMC, including orthogonal analytical strategies for comprehensive characterization
• Perform hands-on execution and technical leadership across a broad range of modalities, including proteins and recombinant proteins, peptides and peptide-drug conjugates, monoclonal antibodies (mAbs) and biosimilars, antibody-drug conjugates (ADCs), mRNA therapeutics, DNA/plasmid DNA/oligonucleotides, viral vectors, and emerging complex biologics (fusion proteins, multispecifics, engineered constructs)
• Apply deep expertise in chromatography platforms (HPLC/UPLC/UHPLC, SEC, IEX, HIC, RP-HPLC, affinity chromatography), mass spectrometry (LC-MS/MS, high-resolution MS, SEC-MALS, native MS, MAM workflows, glycan/PTM characterization), capillary electrophoresis (CE-SDS, cIEF, purity/identity assays), and supporting biophysical techniques (DLS, DSC, UV/fluorescence, MALS, CD, FTIR)
• Lead analytical strategy for complex biologics programs, including method development, qualification, validation, transfer, comparability, stability, forced degradation, and full characterization studies
• Ensure development of robust GMP-compliant methods aligned with ICH Q2/Q6, USP, EP, and GMP requirements, and support regulatory submissions (IND, BLA, IMPD) with high-quality analytical data packages
• Drive innovation in analytical science, including implementation of MAM workflows, high-throughput LC-MS platforms, automated bioseparation methods, and evaluation of emerging technologies in biologics characterization
• Provide scientific leadership and mentorship to junior scientists, including troubleshooting complex bioseparation and mass spectrometry challenges and establishing best practices in analytical development and execution

• BS in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field required; Master's degree or higher preferred, but not required.
• Extensive industry experience in biologics analytical development is highly desirable
• 8–15+ years of experience in biopharmaceutical or CRO analytical development with strong hands-on expertise in bioseparation of large molecules
• Deep technical expertise across analytical platforms, including LC/UPLC/SEC/IEX/HIC/RP chromatography, LC-MS and high-resolution mass spectrometry, CE-SDS, cIEF, SEC-MALS, and complementary biophysical techniques
  Strong scientific knowledge of protein structure and higher-order structure, monoclonal antibodies and biosimilars, antibody-drug conjugates (ADCs), engineered biologics, and nucleic acid-based therapeutics (mRNA, DNA, oligonucleotides)
• Demonstrated experience in comparability, stability studies, and degradation pathway analysis for complex biologics
• Preferred experience includes CRO or client-facing analytical project execution, MAM workflows, advanced LC-MS analytics, glycan mapping and PTM quantification, and automation/high-throughput analytical systems
• Strong scientific writing capability with experience supporting regulatory documentation and submissions
• Proven ability to execute in onsite laboratory environments with strong hands-on bioseparation and multi-platform analytical integration skills
• Ability to manage complex biologics programs in fast-paced, matrixed environments with strong problem-solving and scientific reasoning capabilities
• Effective communicator across scientific, regulatory, and operational stakeholders

Physical Demands:

• Frequency of required physical force: Minimum (moderate)
• Lifting requirements: lifting <50 lbs. often and >50 lbs. on occasion
• Ability to stand on feet for long periods of time
• Ability to lift 50+lbs periodically

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Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to ‘Make tomorrow safer than today’.

When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.

While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development.

Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization.

At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world’s most trusted testing partner”.

All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.