CMC & Supply Chain Compliance Specialist

Corbus Pharmaceuticals Holdings, Inc. Norwood , MA 02062

Posted 5 months ago

The CMC & Supply Chain Compliance Specialist is responsible for establishing, addressing and ensuring compliance of Corbus' GMP activities occurring at Contract Manufacturing Organizations. This position will work closely with CMC, Clinical Supply Chain and Quality Assurance representatives to ensure compliance with all activities for GMP materials. The CMC & Supply Chain Compliance Specialist will also provide quality support for the various functions under its responsibility which include Process Chemistry, Pharmaceutics R&D, Analytical R&D, Clinical Supply Operations and includes quality system support. The successful candidate is self-motivated, independent, highly organized and able to work in a small team environment. Due to the critical nature of this role in Corbus' success, this position reports directly to the Vice President, CMC Operations


  • Responsible for liaising with Quality Assurance on internal and external investigations, deviations and other quality system events to assess impact, root cause analysis and CA/Pas.

  • Track and drive CMC related quality items to closure on-time (investigations, deviations, CAPA, gap assessments, risk assessments, process change controls)

  • Provide regular updates to Quality Assurance in support of monthly reporting and metrics generation

  • Create and implement workflows, processes and/or procedures for approving, organizing and archiving CMC related documents in manual and electronic systems.

  • Creation of CMC and Supply Chain SOP's related to Quality and Compliance.

  • Recommend and influence for changes in practices to bring about a Quality Centric CMC and Supply Chain organization

  • Review of stability protocols, reports and data

  • Tracking, authoring and closing all CMC related investigations, deviations and CAPAs



  • Bachelor's Degree in related field and minimum 5 years of experience in Pharmaceutical Industry in a related CMC, Supply Chain or Quality Assurance role, or the equivalent combination of education, training and experience.

  • Experience with reviewing and dispositioning GxP materials

  • Ability to identify technical problems and suggest resolution of the issues

  • Excellent organizational, interpersonal and decision-making skills, as well as verbal and written communication skills

  • Knowledge of FDA and international regulations and GxP guidelines

  • Comfortable in a fast-paced environment and able to navigate changing priorities

Corbus Culture:

Corbus is a close-knit team of over 100 employees who are high-achievers, innovative, creative and, above all else, passionate about what we do. We hire for personality as well as for skill.

You must thrive in an entrepreneurial and autonomous environment where you will succeed based on your contribution and work ethic, not on your title or rank. At Corbus we take pride in our "family" atmosphere where each person's contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here. Positive, team-oriented people work at Corbus and are rewarded with fun perks like weekly food deliveries to our kitchen, a monthly in-house massage therapist, company-paid classes with Title Boxing, and organized company activities and outings. Additionally, Corbus offers an attractive, comprehensive benefits package.

About Corbus:

Corbus Pharmaceuticals Holdings, Inc. (NASDQ: CRBP) is a Phase 3 clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat inflammatory and fibrotic diseases by leveraging its industry leading pipeline of endocannabinoid system-targeting drug candidates. The Company's lead product candidate, Lenabasum, is a novel, synthetic, oral, selective cannabinoid receptor type 2 (CB2) agonist designed to resolve chronic inflammation and fibrotic processes. Lenabasum is currently being evaluated in systemic sclerosis, cystic fibrosis, dermatomyositis, and systemic lupus erythematosus.

Corbus licensed the exclusive worldwide rights to develop, manufacture and market drug candidates from more than 600 novel compounds targeting the endocannabinoid system from Jenrin Discovery LLC. The pipeline includes CRB-4001, a 2nd generation, peripherally-restricted, selective cannabinoid receptor type 1 (CB1) inverse agonist specifically designed to eliminate blood-brain barrier penetration and brain CB1 receptor occupancy that mediate the neuropsychiatric issues associated with first-generation CB1 inverse agonists. Potential indications for CRB-4001 include NASH, primary biliary cholangitis, idiopathic pulmonary fibrosis, radiation-induced pulmonary fibrosis, myocardial fibrosis after myocardial infarction and acute interstitial nephritis, among others. CRB-4001 is scheduled to enter a Phase 1 study in 2019 followed a National Institutes of Health (NIH)-funded first-in-patient Phase 2 study.

Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Supply Chain Planner 182041

Siemens Corporation

Posted 3 weeks ago

VIEW JOBS 10/1/2019 12:00:00 AM 2019-12-30T00:00 Siemens Healthineers Point of Care Diagnostics Business line is a $700M leading provider of handheld and desktop analyzers and consumables, serving the blood gas, urinalysis and diabetes care markets globally. We are part of the Diagnostics segment that, combined with our Imaging segment and Advanced Therapies segment, make up Siemens Healthineers, a $15B world leader in medical diagnostics. Reporting directly to the Director of Global Planning, the Planner will responsible for leading the Sales & Operations Planning (S&OP) process to effectively balance demand and supply to deliver targeted customer service and inventory performance. This role will be focused on a specific subset of the business and partner directly with those business leaders Duties and Responsibilities Key Responsibilities * Partner with the franchise leadership team to understand strategic and annual business objectives in order to translate them into specific and actionable service level and inventory targets by product and region * Collaborate with key stakeholders in Sourcing, Manufacturing, Distribution/Logistics, Finance and IT to ensure alignment of goals and targets, efficient communication and escalation channels, and accountability for actions and performance * Own, enforce and improve the Sales & Operations Planning (S&OP) process within the scope of the Global Point of Care business; direct accountability for finished goods inventory in the distribution centers and matrixed accountability for raw materials and work-in-process inventory in the plants, focusing on the a targeted set of franchises * Serve as an ambassador for the S&OP process, coaching cross-functional teamwork, problem solving and joint risk decisions * Collaborate with Business and Regional Sales and Marketing to support demand forecasting of both baseline statistical volume and unique event-based volume changes, and continuously improve forecast accuracy * Collaborate with Plant Materials Management to support the capacity planning of operational resources (materials/tools/equipment/people) to ensure alignment with demand, proper contingency and surge, and suitable depth of cross-trained talent * Collaborate with Distribution and Logistics to ensure proper planning parameters are applied, execution is monitored and new requirements are effectively designed into our supply chain flow * Collaborate with IT to ensure global visibility and smart reporting of inventory, volume and key performance metrics; escalate issues an opportunities for improvement where appropriate * Contribute to the balanced scorecard that spans Safety, Quality, Delivery, Inventory and Performance (SQDIP) * Promote a quality culture throughout Planning and Operations, enforcing high quality standards in the management of information flow within and between Siemens sites and business entities as it relates to demand, supply and inventory * Champion the Healthineers Performance System as a means to drive continuous improvement, employee engagement and organizational learning; core methods will include Hoshin Kanri, Value Stream Mapping, Structured Problem Solving, Visual Management, Coaching and Healthy Dialogue * Execute with discipline and continuously improve daily, weekly and monthly standard work in Planning to ensure proper controls, rigorous analytics and effective decision support reporting * Contribute to the continuously improving education platform that provides best practice training in Global Supply Chain Planning Miscellaneous Operational Responsibilities * Establish and monitor key performance metrics, notably leading indicators * Stimulate innovation and creative problem solving by welcoming outside-in perspectives; regularly develop ad hoc analyses to address new and evolving business issues * Promote learning from the past to strengthen and enable proactive planning * Evaluate performance of direct reports based on leadership and results * Ensure excellence in product quality, on time delivery, target setting and strategies for realistic new business objectives providing guidance to subordinate teams, where appropriate * Key Contacts * Reports directly to Director of Global Planning * Regional and Business Sales and Marketing, Plant Materials Management, Distribution & Logistics, IT, Finance * Job Demands * * Innovative thinker who blends strategy, operations, technology, and analytics to produce outstanding business results. * Honest broker who can hold matrix stakeholders accountable to commitments and resolve conflicts based on facts * Confident and effective communicator with strong interpersonal and matrix team-management skills, driven to achieve goals and exceed expectations. * Understands the physics of manufacturing and distribution, as well as the dynamics of demand planning in various market types * Risk Mitigation orientation, capable of leading scenario planning that yields upside, nominal and downside options * Financially astute, analytically rigorous, capable of developing frameworks to assess new situations * Team player Skills & Qualifications (Education and Experience) * Bachelor's degree in an analytical major. MBA is preferred. * 7+ years of general business experience * 3-5 years of progressive experience in Planning of some capacity; some hands on experience in Sourcing, Manufacturing and/or Distribution is preferred * Prior experience working for a company whose products and processes are FDA regulated is preferred * Job ID: 182041 Organization: Siemens Healthineers Company: Siemens Healthcare Diagnostics Inc. Experience Level: Mid-level Professional Job Type: Full-time Equal Employment Opportunity Statement Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law. EEO is the Law Applicants and employees are protected under Federal law from discrimination. To learn more, Click here. Pay Transparency Non-Discrimination Provision Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here. Siemens Corporation Norwood MA

CMC & Supply Chain Compliance Specialist

Corbus Pharmaceuticals Holdings, Inc.