Engineering Structures Elsevier Jobs in Massachusetts

Convergent Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing tumor-selective alpha radio antibodies to target cancer. The company was founded by world-renowned experts in clinical care and research, drug development, and cancer biology, and Convergent’s proprietary platform is licensed from Cornell University. In harnessing the selectivity of antibodies and tumor-destructive potential of alpha radioisotopes, Convergent's radio antibodies precisely target cancer cells with potent, localized radiation.

In addition to the roles and responsibilities outlined below, we value team members who are eager to make an impact and grow with us professionally. We are seeking an individual who enjoys multi-tasking and has the willingness and flexibility to assume additional responsibilities as assigned.

Location: 50 Milk Street, Boston, MA

Reporting to: Caitlyn Harvey, SVP of Technical Operations

Responsibilities

• Create a strategy and lead the MSAT function through CPI, Phase 3 IND submission, PPQ and CPV (this includes API, Drug Substance, and Drug Product).
• Lead technology transfers and author technical documents including reports, standard operating procedures, master batch records, work instructions
• Collaborate with the Development Lead to learn and document the process as well as co-author development protocols and development technical reports.
• Responsible for authoring key IND updates and justifications
• Responsible for authoring MVP
• Provide onsite support at the CDMO, develop a training plan for manufacturing operators, and oversee process execution
• Lead investigations to troubleshoot process execution challenges including RCA
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment

Requirements

• BS and/or MS in Chemical, Biological, or Biomedical Engineering
• 10+ yrs or equivalent combination of education and work experience
• Experience authoring IND sections
• Previous experience with antibody based drug substances and antibody-drug-conjugates
• Detail-oriented with good problem-solving, technical writing and verbal communication skills
• Ability to effectively work in multidisciplinary teams, meet deadlines, and prioritize multiple projects
• Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment
• Well versed with cGMP requirements and working in a regulated environment, including experience as person-in-plan and/or GMP operator.
• Working knowledge of statistical design of experiments (DoE) and RCA.
• Excellent technical writing skills
• Ability to travel up to 25% of the time
• This is a Hybrid role, in office 2 to 3 days a week
• We are considering Greater Boston based candidates only

Nice to haves:

• Knowledge of radiochemistry
• Understanding of analytical methods such as HPLC, SPR, and cell based assays.
• Experience developing scale down models

Equal Opportunity Employer

We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment, including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. We will make reasonable accommodation for qualified individuals in accordance with applicable law.

Are you a hands-on Quality leader who thrives in high-accountability environments and believes great culture drives great results? We’re looking for a Site Quality Manager to lead all Quality functions at our North Billerica facility and play a key role in shaping performance, compliance, and team development.

If you’re passionate about building strong teams, driving continuous improvement, and ensuring world-class quality standards — this is your opportunity to make a measurable impact.

As the Site Quality Manager, you will:

• Lead and continuously improve our AS9100 / ISO 9001 Quality Management System
• Oversee MRB, NCMRs, CAPAs, SCARs, RMAs, and root cause investigations
• Direct all inspection activities (In-Process, Pre-Mold, Final) including AS9102 First Article Inspections
• Ensure cable and harness assemblies meet IPC-620, J-STD-001, AS9102, and customer requirements
• Review and approve work order packages, C of Cs, and shipment documentation
• Monitor quality metrics, defect trends, and drive Zero Defect initiatives
• Lead internal audits and support customer and certification audits
• Partner cross-functionally with Production, Engineering, Planning, Procurement, and Corporate Quality
• Develop and mentor the Quality team, building capability and accountability at every level
• Serve as the primary customer liaison for quality-related matters

Technical Expertise:

• Strong working knowledge of AS9100 Rev D and ISO 9001
• Experience with AS9102 First Article Inspection
• Familiarity with IPC-620 and J-STD-001 (Space Addendum a plus)
• Deep experience with NCMR, MRB, CAPA/RCCA, and root cause analysis
• Aerospace or military manufacturing background preferred
• Ability to read and interpret engineering drawings, wire lists, and MIL specs
• Experience in build-to-print cable/harness manufacturing is a plus

Leadership & Impact:

• 5+ years in Quality Assurance/Quality Control within manufacturing
• Prior team leadership experience
• Proven track record leading corrective actions to closure
• Experience conducting internal audits under AS9100
• Strong analytical skills with the ability to turn data into actionable insights
• Clear, professional communication with customers and suppliers

This is a high-visibility leadership role in a fast-paced aerospace manufacturing environment where quality is mission-critical.

Quality Manager – Direct Hire | 1st Shift

Chelmsford, MA

1st Shift

Direct Hire

About the Role

We are seeking an experienced Quality Manager to lead all Quality operations within a growing aerospace/advanced manufacturing environment. This role oversees quality systems, compliance, audits, supplier management, documentation, and continuous improvement initiatives. The ideal candidate brings strong leadership, deep understanding of AS9100, and the ability to drive a high‑performing quality culture.

Responsibilities

• Lead and develop the Quality team through coaching, training, performance reviews, and career planning.
• Manage and maintain all aspects of the Quality Management System (QMS), including AS9100 compliance, audits, and procedure updates.
• Oversee monthly/annual metrics, documentation control, ECO processing, and risk & opportunity tracking.
• Manage CAPA processes (customer, supplier, internal), NMR/MRB workflows, and GIDEP alerts.
• Serve as the primary quality interface for customers and suppliers, supporting reviews, issue resolution, and status updates.
• Support RFQ and Contract Review processes by validating requirements, flow‑downs, QA codes, and risk entries.
• Oversee supplier approvals, certification tracking, site visits, and quarterly supplier ratings.
• Manage calibration systems, PM documentation, government property equipment logs, and inspection activities (incoming, in‑process, final).
• Support NIST/CMMC compliance with IT and complete actions related to infrastructure and cybersecurity.
• Conduct new‑hire onboarding and coordinate training with HR and Manufacturing leadership.
• Maintain compliance with NAVSUP GFP requirements and conduct monthly walk‑around assessments.
• Drive continuous improvement across all quality processes and cross‑functional operations.

Minimum Requirements

• Bachelor’s degree in Business, Engineering, or related field
• 10+ years of relevant experience
• Strong written and verbal communication skills
• Analytical problem‑solving skills
• Background in Total Quality Management and process improvement
• IPC certifications a plus
• Ability to travel to customer sites as needed
• Attention to detail and strong organizational ability
• Experience in printed circuit boards or related manufacturing preferred

Infra-Red Building and Power Service is seeking a motivated and results-driven Outside Sales Account Representative to join our growing team. This position is ideal for a self-starter with experience in electrical services, power generation, or technical sales who thrives on building relationships and delivering solutions that solve real-world customer challenges.

About the Role

The Outside Sales Account Representative will be responsible for developing new business, managing existing accounts, and promoting our electrical testing, power generation, and building service solutions. This role combines relationship-based selling with technical expertise and requires a professional who can manage complex sales cycles and communicate effectively with contractors, engineers, and facility managers.

Key Responsibilities

• Develop and maintain strong relationships with electrical contractors, distributors, generator dealers, end users, utilities, and engineering consultants
• Identify project opportunities and influence specifications early in the sales cycle
• Conduct sales calls, site visits, and technical presentations
• Educate customers on power generation and electrical testing services and applications
• Grow existing accounts while actively pursuing new business opportunities
• Track sales activity and customer interactions through CRM systems
• Attend industry events, trainings, and trade shows to stay current with industry trends
• Travel to customer locations as needed

Qualifications

• 5+ years of experience in outside or technical sales, preferably in power generation, electrical testing, or related industries
• Strong technical aptitude with the ability to interpret electrical specifications and schematics
• Proven ability to develop long-term customer relationships and close business
• Excellent communication, negotiation, and presentation skills
• Proficiency in Microsoft Word, Excel, and CRM platforms
• Valid driver’s license and clean driving record
• College degree in engineering, business, or related field preferred (or equivalent industry experience)

What We Offer

• Competitive compensation package with performance incentives
• Opportunity for career growth within a respected and expanding company
• Supportive team environment with ongoing technical training
• The ability to represent industry-leading services in a growing market

If you are a motivated sales professional ready to grow with a company that values expertise, relationships, and results, we encourage you to apply.

• Learn more about our company at .

**This role covers the Front End process: Highly Automated Forge and Foundry **

Salary Expectations:

-125-140k

-25% bonus

Keys to this role:

-High manufacturing IQ

-24/7 operation 3 shifts 25 union employees with 3-6 operators per shift.

-Must be a data driven leader

-Must have some sort of forge or foundry experience

PURPOSE:

Manage the Front-End Manufacturing activities for the Worcester, MA facility. Assure that production variable cost and productivity goals are met or exceeded. Improve on-time delivery to customers to targeted level. Adhere to process control/quality criteria so as to reduce rework and scrap. Manage fixed and variable budgets. Full P&L Responsibility for the Isothermal Forge Shop and mult prep.

ESSENTIAL JOB FUNCTIONS:

• Coordinate and manage a full complement of production and production support activities.
• Interface and work with key staff positions: Materials Management, Product Engineering, Quality, Accounting, HR, IT, etc.
• Drive cost reduction and continuous improvement in the attainment of corporate goals.
• Responsible for cost control and budget attainment.
• Meet required customer shipping schedules.
• Establish working effective relationship with Union leadership.
• Establish and execute capital planning efforts supporting manufacturing

With more than 100 years of experience, Sika is a worldwide innovation and sustainability leader in the development and production of systems and products for commercial and residential construction, as well as the transportation, marine, automotive, and renewable energy manufacturing industries.

Sika is a specialty chemicals company with a globally leading position in the development and production of systems and products for bonding, sealing, damping, reinforcing, and protection in the building sector and industry. Sika has subsidiaries in 103 countries around the world, produces in over 400 factories, and develops innovative technologies for customers worldwide. In doing so, it plays a crucial role in enabling the transformation of the construction and transportation industries toward greater environmental compatibility. Approximately 33,000 employees generated CHF 11.20 billion in sales in 2025.

Sika is looking for an experienced Production Supervisor to join its growing team in the Canton, MA area for our Roofing business.

The A Shift Supervisor will support a team of 10 Machine Operators and will work 6am- 6pm Su, Mon, Tues and every other Wednesday.

Salary Range: $30 - $35/hour with a 10% shift differential based on education, experience and qualifications of the applicant

• Assign responsibilities to employees and oversee their development
• Ensure that employees are operating in a safe manner and that they adhere to all Sika, OSHA, and other regulatory requirements
• Periodically audit employees on their job functions and work with them to help develop their skills
• Work with management and engineering regarding coordination of raw material and process equipment trials
• Submit work orders to the Fiix CMMS system and follow through with verbal communication to maintenance technicians regarding said work orders
• Ensure that all team members are engaged in Sika Safe
• Collect daily production sheets from the Lead Operator, Mixer Operator, and Extruder Operator and document them accordingly. Reconcile any variations in MES system
• Work with quality assurance to ensure that the membrane produced meets all ASTM and local guidelines
• Foster a positive work environment through active communication and transparency with employees
• Communicate the daily/weekly production schedule with team in mandatory daily shift starter meetings
• Encourage team to maintain clean work areas using 6S principles
• Meet regularly with Production Manager and planning team to ensure that the proper materials/resources are in place for successful, on-time manufacturing
• Communicate daily results to the management team through shift report email
  
  

• 5+ years of supervisory experience in continuous manufacturing
• High School Diploma/GED
• Proficient in computers and MS Office (Word, Excel, Outlook)
• Some experience using SAP or ERP system recommended
• Excellent verbal and written communication skills
• Proven ability to work in a team environment
• The ability to coordinate product changeover on short notice
• Some extrusion, spreadcoating, and/or dry blending knowledge is preferred
• Ability to operate a forklift
• Ability to stand for extended durations
• Ability to lift 50 lbs
  
  

• 401k with Generous Company Match
• Bonuses
• Medical, Dental, and Vision Benefits
• Paid Parental Leave
• Life Insurance
• Disability Insurance
• Paid time off, paid holidays
• Floating holidays + Paid Volunteer Time
• Wellness/Fitness Reimbursements
• Education Assistance
• Professional Development Opportunities
• Employee Referral Program & More!

Sika fosters a culture of entrepreneurship, empowering each individual to make decisions, learn from experiences, and shape their own career path. The safety and well-being of employees are top priorities at Sika, with a strong commitment to open communication and maintaining a safe workplace. In addition, Sika actively contributes to the community and promotes sustainability by giving back, minimizing environmental impact, and embracing social responsibility.

Sika Corporation is committed to a work environment that supports, inspires, and respects all individuals that apply. As an equal opportunity employer Sika will consider all qualified applicants without discrimination on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, age, disability, national or ethnic origin, or other protected characteristics.

Sika Corporation is committed to a work environment that supports, inspires, and respects all individuals that apply. As an equal opportunity employer Sika will consider all qualified applicants without discrimination on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, age, disability, national or ethnic origin, or other protected characteristics.

We offer competitive salaries, aligned with local market benchmarks and the specific scope and responsibilities of each role. Compensation is determined based skills relevant to the position, education and/or training. We are committed to fair and equitable pay practices in accordance with applicable laws and regulations.

Minimum Requirements

• Associate’s or Bachelor’s degree in Manufacturing, Electronics, Industrial Engineering or equivalent experience
• 3 to 7 plus years in SMT/PCB electronics manufacturing
• 1 to 3 plus years in a supervisory or leadership role preferred
• Strong written and verbal communication skills
• Ability to read PCB drawings, BOMs and work instructions.
• Familiar with MES/ERP systems
• Understanding of reflow profiling and stencil design

Responsibilities

Responsible for overseeing daily SMT production operations, ensuring efficient workflow, product quality, equipment performance, and adherence to safety and manufacturing standards. This role supervises SMT technicians and operators while driving continuous improvement in productivity, yield, and process reliability.

• Supervise day-to-day SMT manufacturing activities (screen printing, pick-and-place, reflow, AOI, SPI).

• Ensure production schedules are met on time and within quality standards.

• Monitor line performance, throughput, and downtime.

• Coordinate job changeovers and line setups.

• Lead, coach, and train SMT operators and technicians.

• Assign work, manage staffing levels, and approve timecards/overtime.

• Conduct performance reviews and disciplinary actions when required.

• Promote teamwork and a culture of accountability.

• Ensure compliance with IPC standards (IPC-A-610, J-STD-001).

• Partner with Quality and Engineering to resolve defects and yield issues.

• Drive root cause analysis and corrective actions (RCA/CAPA).

• Monitor solder paste quality, placement accuracy, and reflow profiles.

• Oversee SMT equipment operation: printers, placement machines, reflow ovens, conveyors, AOI.

• Coordinate preventive maintenance and calibrations.

• Escalate equipment failures and support troubleshooting.

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.

Salary Range: 65k-95k

Title: Materials Management Specialist/Senior Materials Management Specialist

Location: Woburn, MA (on-site 5 days per week)

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

The Role: 

Works under the operations team and in coordination with the Quality Assurance (QA) team to oversee the entire flow of materials, from procurement and inventory control to receipt to storage and distribution. Ensure all materials meet defined specifications and are available for intended use and quantities to support user needs. Provide continuous improvement efforts in purchasing, planning, and warehousing. Key responsibilities include strategic sourcing, inventory optimization, demand forecasting, supplier negotiation, and managing logistics for clinical distribution while reducing waste and costs.

Responsibilities: 

• Develop material strategies, forecasts demand, plans production and inspection schedules, and aligns material flow with business goals.
• Maintains optimal inventory levels, conducts physical counts, investigates discrepancies, and implements lean manufacturing principles.
• Supervises purchasing, inventory, and warehouse activities in a manner consistent with cGMPs.
• Assists Quality Assurance to assign and document the status for all materials used in the development of Vaxess products.
• Implements initiatives to reduce waste, cost efficiencies, and improve financial performance.
• Sources, negotiates, and purchases goods and services, building strong supplier relationships and ensuring quality and reliability.

Qualifications: 

• 2 to 5 years in Material Management or Shipping and Receiving in the Pharmaceutical or Medical Device Industries working in a cGMP Environment.
• Strong understanding of supply chain, logistics, and inventory principles.
• Experience with ERP Systems/SAP preferred.
• Experience with standard cGMP storage requirements for Quarantine, Release and Rejected materials.
• Experience with the receipt, storage, distribution, and shipping of temperature-controlled materials.
• Bachelor’s Degree in a relevant field (Logistics, Biomedical Engineering or Health Care Management and certifications (APICS, ISM) preferred.

At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to   

Company Description 

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. We are looking for a Master Scheduler to join our dynamic team in New England. 

Job Summary 

We are seeking a Master Scheduler who thrives in high-complexity, fast-paced environments. This isn’t just a data entry role; you will be the "engine room" of our site operations, bridging the gap between long-term strategic planning and daily execution. You will play a pivotal role in evolving our Sales & Operations Planning (S&OP) process and leveraging technology to navigate the intricacies of contract manufacturing. 

Key Responsibilities / Accountabilities

• 
  
• Maintain the high-level site capacity and resource forecast within Saviom while simultaneously managing the granular, day-to-day production schedule in Microsoft Dynamics 365 (D365).
  
• Ensure alignment between R&D, Clinical, and Commercial timelines to maximize suite utilization and labor efficiency.
  
• Drive the site toward achieving "Ready to Execute" (RTE) milestones and maintaining high "Schedule Adherence" percentages.
  
• Lead the implementation of a fully integrated S&OP process, facilitating cross-functional meetings to align Finance, Business Development, and Operations.
  
• Evaluate the effectiveness of current scheduling tools. Identify opportunities for AI integration or advanced data analytics to improve predictive modeling and bottleneck identification.
  
• High emotional intelligence with the ability to translate technical constraints into business impacts for stakeholders.
  
• Aggregate and interpret complex datasets across multiple platforms to provide actionable insights for site leadership.
  
• Experience in a regulated environment (API/Biologics) and familiarity with platforms like Veeva is a significant plus.
  
• Ability to forecast 6–18 months out while managing the next 24 hours.
  
• Communication Bridge: Act as the primary point of contact for internal teams and external clients regarding timeline commitments and capacity constraints.
  
• Quality Integration: Author and manage quality events (Deviations, CAPAs, or Change Controls) within our QMS (Veeva Vault), ensuring that scheduling changes remain compliant with cGMP standards.
  
  • 
    
  • Other duties as assigned. 
    
  
  

Qualifications

• 
  
• CDMO Experience. You understand the unique "pivoting" required in a contract manufacturing environment where client needs and project scopes can shift rapidly.
  
• Advanced experience with Microsoft D365 and resource management software (like Saviom) is highly preferred.
  
• Ability to look at disparate data points and see the "big picture" of site capacity, helping the business navigate complexity with strategic foresight.
  
• Exceptional ability to resolve resource conflicts and timeline bottlenecks.
  
• 5–8 years of progressive experience in planning or engineering, ideally within pharmaceutical, biotech, or specialty chemical manufacturing.
  
• Strong leadership and interpersonal skills with the ability to influence without direct authority.
  
• Demonstrated ownership, accountability, and follow-through in complex, cross-functional environments.
  
• Excellent communication and presentation skills (written and verbal).
  
• Proficiency with ERP systems (SAP, Oracle, or Microsoft D365) and Microsoft Office Suite (Excel, PowerPoint, Word). Comfortable with/able to thrive in conditions of change and complexity.  
  
• Proven and strong project and change management capabilities. 
  
• Strong analytical and qualitative skills desirable. 
  

Pay Range: $80,000 - $95,000

Our Commitment:

• 
  
• Health & Wellness: Comprehensive health & Wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies. 
  
• Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs.
  
• Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
  
• Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We are committed to ensuring that everyone can bring their full self to work and thrive in their career.
  

How to Apply: 

At Veranova, we are on a mission to meet people that believe in our values and can contribute to the team in a variety of ways. Please visit   to view all open roles and join our Talent Community to stay connected and learn about opportunities as they arise. 

We value a range of experiences and perspectives. If you want to be part of improving and saving the lives of patients, we encourage you to apply regardless of whether you meet every qualification listed. 

Additional Information:

Applicants for this role must be authorized to work in the United States without further employer sponsorship.  

Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting. 

All your information will be kept confidential according to EEO guidelines.

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.

All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.

TheSenior Process Engineer is responsible for designing, developing, optimizing and troubleshooting manufacturing processes in a manner that meets safety, quality and operational performance expectations. This position provides leadership and creativity in the formulation development, process development and optimization, scale up and manufacturing. The key function of this role is to identify and solve problems in the manufacturing process transfer and scale up, and deliver effective, safe and efficient manufacturing processes for parenteral drug products. The Senior Process Engineer is hands-on, able to handle multiple tasks with sound planning and communication and providing training and support to peers.

This role will:

• Analyze organic or inorganic pharmaceutical excipients to determine chemical or physical compatibilities with active drug molecules for the development of stable pharmaceutical product
• Evaluate changes in the composition/stability of pharmaceutical products due to changes in variables such as heat, light, or chemical catalysts for quantitative or qualitative analysis
• Propose and prepare formulations with different excipients or solvents to conduct experiments and analytical testing at laboratory scale
• Propose and develop lyophilization product and process or other complex formulation process such as liposome, TFF and viscous product
• Take an active part in scale-up and technology transfer of newly developed products from R&D to manufacturing
• Identify and order materials required to perform development and manufacturing
• Identify tooling and equipment required to perform development and manufacturing
• Create documents for laboratory/manufacturing operations and quality such as master batch records, study protocols, engineering batch record, process characterization reports, standard operating procedures (SOP), etc. Review these documents for their compliance with cGMP and FDA standards
• Due diligence on manufacturing process design and risk analysis to ensure operation safety, efficiency and quality
• Propose testing procedures for analyzing CQA and coordinate with quality control testing to ensure the quality of finished drug product
• Compile and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions
• Analyze in-process and release testing results to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA) of the pharmaceutical product
• Maintain ownership of assigned laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed
• Study effects of various manufacturing techniques or packaging configuration on the composition or stability of pharmaceutical product
• Develop, improve or customize equipment, formulas, processes or analytical methods to maintain quality of pharmaceutical product
• Write technical papers or reports or prepare standards and specifications for processes, facilities, products, or tests
• Provide leadership in daily operations, and have employees incorporate these compliance practices into their daily routines
• Lead/support validation activities including equipment validation and process validation
• Lead problem solving and investigate quality events related to formulation process or batch records
• Propose and lead process improvement initiatives to improve operating performance and laboratory safety procedures to ensure compliance with the cGMP and FDA standards
• Lead or participate in root cause analysis and quality event investigation such as OOS and deviations
• Supervise, mentor and develop team members or relevant personnel across departments

This role requires:

• A minimum of three (3) years of experience in pharmaceutical research and manufacturing
• Bachelor’s degree or above in Chemical Engineering, Chemistry, Biology or Pharmaceutical Science
• Experience in sterile manufacturing is preferred
• Experience in lyophilization and terminal sterilization techniques are a plus
• Knowledge of parenteral drug product manufacturing
• Proficient with calculation, data analysis, statistics and applied mathematics