Veranova Pharma Jobs in Usa

The Intake Specialist role works to support the Patient Assistance Program (PAP) through providing initial triaging of patient applications, including data entry and coordination of work through the appropriate channels as determined by established business rules.

Responsibilities:

•Completes the intake process of all applications into Customer Relationship Management System (CRM)

•Associates and tags all images to the patient, data enters all information including patient demographic information, physician information, drug information, and all relevant application data such as income information, household information and insurance information into the CRM

•Conducts initial assessment of application for missing information and completes missing information patient outreach process to obtain required data

•Completes initial assessment of simplified application

•Identify appropriate work flow based upon business rules

•Collaborate cross functionally to ensure processes are followed according to business rules and policies

•Ensure all patient cases are documented in the CRM in accordance with all business rules and policies

•Conduct renewal and year end recertification’s process as determined by the Patient Assistance Program

•Readily assists on special project within job scope to improve reimbursement optimization when requested by management

Manages incoming and outgoing mail

Qualifications:

•High school diploma or equivalent required. College or a 2-year Associate Degree is preferred

•A minimum of 1-3 years’ experience within an office or administrative setting

•Exposure to core insurance (Medical and Pharmacy Benefit) knowledge a plus

•Strong attention to detail and work independently with minimal direction

•High quality customer service skills

•Ability to express ideas clearly in both written and oral communications

Shift Schedule:

Variable, including weekends and evenings as-needed, typically 8hr duration, always coordinated before shift assignment. The hours will be variable depending on projects at the clinic, and may include days for what would typically be screening assessments or admission assessments, or evenings/weekends for study-related procedures such as dosings, ECG review and interpretation, lab review and interpretation.

Description:

• The duties may include screening procedures such as routine physical examinations of healthy volunteers, ECG interpretation, review of labs, eligibility assessment for prospective study participants, management of adverse events, on-site supervision of investigational product dosing, and related duties.

• Delegates study responsibilities as appropriate to trained study staff

• Possesses a working knowledge of GCP/ICH guidelines, Clinic SOPs, QA/QC procedures, and Investigator 1572 Form

• Reviews Investigator’s Brochure prior to performing any study procedures

• Performs all study responsibilities in compliance with the IRB approved protocol

• Reviews screening documentation and approves subject for admission to study

• Reviews admission documentation and approves subject for randomization

• Interprets ECGs within agreed Sponsor timeline

• Documents all findings in subject specific source documents

• Provides ongoing assessment of the study subject/patient to identify Adverse Events

• Ensures proper documentation and reporting of all Adverse Events and Serious Adverse Events

• Reviews and evaluates all study data and comments to the clinical significance of any out of range results

• Performs physical examinations as part of screening evaluation and active study conduct

• Provides medical management of adverse events as appropriate

• Completes all study documentation in accordance with the study specific requirements

• Communicated with Sponsors and auditors as requested

• Participates in on-call activities as required to ensure adequate medical coverage

• Monitors safety and well-being of study participants at all times

• Provides coverage for the Clinic Principal Investigator

•They should be able to work and thrive in a team-based environment.

The Media Prep team within the STL Transformation Production Team is seeking a highly motivated and fast-paced individual to participate in the critical work to support the pipeline by supplying sterile agar and liquid products to customers around the world in a timely manner. The successful candidate will work with chemical components and different forms of equipment. Desire to work within a team environment is essential to deliver a high-quality product to the customer in a timely manner.

Required Skills: A Bachelor's degree in biology, chemistry, cellular biology or related field is required. Experience working in a laboratory environment is highly desirable. Attention to detail, database experience, ability to work in a team setting, and strong communication and organizational skills are essential. Sterile technique experience is a plus. Must be willing to work up to a 40 hour week with shift times at the discretion of the manager dependent upon production needs.

*Important you are able to work on the 1st shift (6:45 a.m. – 3:30 p.m.) for 4 weeks to train.

Then will be assigned to the 2nd shift (3 p.m. – 11:45 p.m.) or the 3rd shift (10:30 p.m.- 7:15 p.m.) depending on availability.

Job Purpose

Able to perform various inspecting, labelling and packaging operations. Tends machines that perform one or more packaging functions, such as packing, or bundling.

Major Accountabilities

• Handling of components on packaging line and monitors for defects.

• Inspects filled container or package to ensure product is according to specifications.

• May weigh finished products to detect missing components.

• Clears line culls and documents all components discarded.

• Prepares shippers, inspects finished product and packages into shipper. Seals, labels, and stacks shipper.

• Fills cartons, carriers or shippers by hand with product, labels, literature or applicators.

• Performs cleaning tasks on machine during or after machine operation.

• Maintains compliance with SOPs, good documentation practices (GDP), training requirements, Company and safety policies and current Good Manufacturing Practices (cGMPs).

• Verifies correct lot code/exp. date on all pkg. components/finished goods.

• Performs packaging line assignment maintaining line throughput and quality standards.

• Contributes to the team by supporting other lines and roles as necessary to maintain operational efficiency.

• Performs rework/re-inspection of components/finished goods with minimal conversation and focus on product defects.

• Performs various housekeeping duties such as sweeping/mopping floor, cleaning equipment, fixtures, windows, and walls as needed.

• Perform minor adjustment on the equipment and documents work performed.

• Participates in training of new employees.

• Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.).

• Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and safety Behaviors.

Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, employee requires training under OSHA’s HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander.

In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16.

All employees that have received the above-mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA.

Key Performance Indicators (knowledge, skills, and abilities expected of an associate to be effective in this role.)

• Solid English reading/comprehension written and verbal communication skills required to understand and communicate to others detailed cGMPs, SOP's, FI’s, and production equipment cleaning instructions

• Basic mathematical skills and ability to work with numbers to accurately count components, waste and finished goods products.

• Participate in Safety Program by complying with all and preventive measures (i.e., wearing Personal Protective Equipment (PPE).

• Alerts Supervision, Mechanics, Quality personnel to safety, quality and equipment performance problems when they occur.

• Work on projects independently or in a team environment, actively participate on teams ex. (continuous improvement initiatives)

• Perform key roles in a manner that promotes teamwork, is respectful of others and is aligned with the companies behaviour expectations.

• Takes initiative and works autonomously to meet production requirements.

• Continues to develop and learn new skills, which will allow for further advancement within the organization.

Ideal Background

Education: • High School Diploma or GED. Associates Degree preferred. Equivalent experience can be considered in lieu of HS Diploma

Experience: • Minimum of one year production experience

• Ability to lift 30 lbs. and maintain a high level of physical activity

Job Title: HRBP

Job Tyle: Full Time

Job Location: Onsite Cranbury/South Plainfield NJ

Job Responsibilities:

Business Partner:

• Acts as a point of contact for the employees and managers in the business unit;
• Conducts ongoing supply and demand support on current and future staffing and skill needs;
• Source candidates using a variety of search methods to build a robust candidate pipeline;
• Collaborating with department managers to compile a consistent list of requirements;
• Ensure all screening, hiring, and selection are done in accordance with employment laws and regulations;
• Actively identifies gaps, proposes and implements changes necessary to cover labor law risks;
• Manages complex and difficult HR Projects cross-functionally;
• Builds a strong business relationship with the internal client;
• Collaborate with colleagues in the human resources department to develop policies, programs, and solutions.
• Acts as the performance improvement driver and provokes positive changes in performance management;
• Provides day-to-day consultation to leadership on a variety of actions including ER issues, policy interpretation & application, and talent management.
• Responsible for the compensation & benefits policy-making, pension schemes, and social relations;
• Works closely with employees to improve work relationships, build morale, and increase productivity and retention.

HR Operation -

• Oversees end-to-end payroll processing, ensuring accuracy, compliance, and timely payment.
• Manages the onboarding and offboarding process, including documentation, system access, exit interviews, and compliance checks.
• Administers employee benefits programs such as health insurance, pension, leave, and other local statutory benefits.
• Maintains and updates HRIS systems, ensuring data accuracy, timely updates, and reporting for decision-making.
• Supports performance review and talent review cycles, including calibration sessions, follow-ups, and action plan implementation.
• Tracks and reports key HR metrics (e.g., headcount, turnover, attendance, performance ratings) to support data-driven HR strategies.
• Ensures all employee records and employment documents are maintained in compliance with legal and company standards.
• Supports annual salary review, bonus, and incentive processes in coordination with the global HR team.
• Contributes to continuous improvement of HR operational processes and employee experience.

Requirements:

• 5 + years' experience in human resources management within the pharmaceutical industry is required;
• Previous experience in recruitment, talent development, and employee relations a plus;
• In-depth knowledge of legal requirements related to human resources including workers’ compensation, union relations, and federal and state employment laws;
• Excellent communication and interpersonal skills.

We are seeking a dynamic individual to manage the day-to-day operations in a Biotech environment. This is an exciting and unique opportunity to support our Pharmaceutical Development team’s office and lab space. The successful candidate will be able to thrive in a fast-paced, ever-changing environment, and manage competing priorities, while maintaining a professional demeanor with employees.

In this critical role, you will serve as the primary interface between our company and its service providers, vendors, and consultants. This position requires great attention to detail, organization, and professionalism, and the ability to maintain an efficient business environment.

Responsibilities, including but not limited to:

·Ensure smooth daily operations of the office environment, making sure employees have a clean and safe office.

·Greet and check in visitors and vendors as required, directing them to the appropriate person as needed.

·Troubleshoot any office issues and escalate to the appropriate teams as needed.

·Coordinate with the Facilities team to manage all ongoing facilities-related issues, including maintenance requests submitted by employees, cleanliness of the office space, as well as landlord relations.

·Manage facility service coordination: office supplies, vendors, non-lab equipment, space planning, and office expansion efforts.

·Develop and manage relationships with catering sites for weekly lunches and events.

·Maintain an effective file organization for administrative projects and office files that are accessible to the team if needed.

·Ensure office and operations security by maintaining the security access database, file keys, access cards, and office keys

·Provide human resources support and miscellaneous administrative project support as necessary, ex: monitoring on boarding of new employees to ensure a positive employee experience

·Sort and distribute incoming mail to the appropriate recipients

·Event planning as needed.

Qualifications:

·Bachelor's degree Preferred

·At least 2-4 years’ experience in a life sciences environment preferred

· Proficiency in Windows operating systems, Outlook, Word, Excel, and general office equipment

· Ability to multitask with several priorities and maintain a high standard of discretion and confidentiality

·Excellent communication and interpersonal skills

· Flexible, confident, and driven toward results

• · Ability to work with minimal supervision

Title: CSPV Project Manager IV/Associate Director

Job Schedule:

Candidate must be able to come into the office at least once a week. Main duties will include: Leading cross-functional teams in project management and execution for key initiatives across CSPV Supporting the Management Office and Business Excellence lead in implementing PMO structure within CSPV Collaborate with CSPV leadership to drive Business Excellence activities supporting the globalization of CSVP.

Responsibilities include:

• Project management, including aligning with stakeholders, setting objectives, developing, and tracking project plan, timelines, and milestones, tracking deliverables, resolving key issues and achieving desired outcomes.
• Generating and reporting status reports to leadership
• Generating and tracking communication plans to key stakeholders Identifying risks, issues, and dependencies
• Facilitating global, cross-functional, collaborative discussions to drive outcomes

Skills:

• Need to have drive; take initiative; and be proactive Strong communication, organizational, and management skills
• Minimum 7 years Project Management in Pharmacovigilance or Clinical Development experience in pharmaceutical industry required Ability to independently manage priorities by organizing workload efficiently Demonstrated ability to manage cross-functional teams to a desired outcome
• Knowledge of MS Suite (Excel, PowerPoint, Word, Visio, Project) PMP certification preferred but not required

Education: Bachelor’s degree in science, management, or related degree.

Pay $37-$39 per hour DOE

Seeking a tactical, detail-oriented Quality professional to support external-facing quality records related to raw material suppliers. The ideal candidate will have 3-5 years of hands-on experience managing deviations, change controls, and CAPAs using systems like TrackWise or Veeva. A strong grasp of root cause analysis and investigation review is essential. Candidates should have a background in biotech or medical device industries, with the ability to operate in a fast-paced, remote environment. Bachelors Degree is best but associate-degree holders with deep experience (10+ years) will be considered. Overqualified individuals (e.g., former directors or PhDs) and those without relevant quality records experience should not be submitted.

Quality records experience working with suppliers would be a home run candidate.

Basic project management skills required.

The Specialist Manufacturing is expected to own and execute under minor supervision all the processes related to deviations (minor and majors), Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR /EN), and Change Control quality records. This Specialist Manufacturing will act as the External Supply representative across functional teams and drive closure of quality records in a timely manner. The Specialist Manufacturing, External Supply owns and manages quality records originating from manufacturing sites across the network. In addition, this role will be the main External Supply quality record owner point of contact for New Albany, OH site.

Responsibilities:

- Address and close quality records (Deviations, Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR /EN), and Change Control) under the company's quality management system procedures and ensures compliance with regulatory agency requirements.

- Monitors and investigate deviations owned by External Supply and implements corrective / preventive actions. Partner cross-functionally across the site to ensure maturity and execution of robust Deviations / CAPA process

- Build and present quality records summaries for Senior Management review. Provide timely and comprehensive process and status updates to senior management

- Support New Albany, OH site as the external supply quality record owner main point of contact and collaborates with the site and technical teams to evaluate observed supplier related defects.

POSITION SUMMARY: The Sr. EHS Specialist is responsible for complex technical work within a range of EHS disciplines.The Sr. EHS Specialist will assist and support to the Associate Director of EHS in the development, implementation, and monitoring of the site’s EHS programs designed to protect the health, safety, and well-being of all Ash Stevens employees, visitors, contractors, the Community, and the local environment as well as compliance with all relevant EHS regulations and best industry practices.

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, MIOSHA, MI DEQ, and related EHS procedures, policies, and practices.
• Consistent support of Ash Stevens’ mission and values.
• Identify and protect the original technical information as part of the company property.

KEY ACCOUNTABILTIES:

• With limited supervision, assist and support the Associate Director of EHS with the development, implementation, and continuous improvement of all EHS management systems and programs.
• Support business plan KRAs/goals and develop and monitor to ensure goals are achieved.
• Develop implement, document, and periodically review Company training programs related to EHS to protect workers and satisfy regulatory and site requirements.
• Develop, review, approve and implement SOPs, Work Instructions, and all other EHS documents.
• Support site management with incident investigations, root cause analyses, and assignment & tracking of CAPAs as needed.
• Partner closely with internal cross-functional stakeholders to communicate, secure support, and inform the facility of EHS compliance risks and gain alignment on EHS initiatives and priorities.
• Ensure that the site complies with applicable EHS regulations and Company requirements, guidelines, and policies and takes the necessary steps to prevent non-conformances.
• Ensure that all EHS reporting, both internally and externally, is conducted timely and accurately.
• Assist with safety evaluations and risk assessments (JHA, PHAs, HAZOPs, FMEAs, PSSRs, etc.) of new products, processes, facilities, and equipment and recommend CAPAs to improve safety performance.
• Provide technical support for EHS programs (LOTOTO, Hazcom, Respiratory Protection, Chemical Hygiene, etc.)
• Assist with the development of annual EHS KRAs, goals, plans, objectives, and budget as directed by the AD.
• Complete requisite environmental reporting (Tier 2, biennial hazardous waste, air emissions, TRI, and stormwater) as directed by AD.
• Reporting injury/illness data electronically to OSHA & generating and posting requisite site reports
• Assigning and managing EHS education and training using MasterControl software system.
• Conducing new hire orientation (NHO) safety training and education as needed.
• Maintain and control site SDSs for RMs, SMs, IPs, and FPs per Hazcom Standards.
• Conduct qualitative/quantitative exposure assessments for hazardous materials and HPAPIs.
• Assessing site compliance with corporate policies/guidelines and federal, state, and local regulations through periodic workplace audits and walkthroughs (Gemba walks).
• Responsible for guiding Site Safety Committee (SSC) activities and initiatives.
• Work closely with Facilities, Engineering, Manufacturing, and Laboratory teams to ensure contractors and subcontractors work in compliance with all site EHS requirements (Safe Work Permits, PRCS entries, LOTOTO, hot work, etc.)

EDUCATION/EXPERIENCE:

• Bachelor’s degree in EHS, Engineering, Chemistry, Industrial Hygiene, or similar degree required.
• Master’s degree in EHS or related field preferred.
• Minimum of 5 years of EHS experience in a pharmaceutical manufacturing environment preferred
• EHS Certifications are a plus (CSP, CIH, QEP, CHMM)
• Sustainability & ESG experience are a plus.
• SDS authoring
• HPAPI containment and isolation equipment and practices.

JOB COMPETENCIES

• Excellent organizational and planning skills.
• Strong leadership and ability to influence all levels of employees.
• Strong problem solving/troubleshooting skills.
• Strong auditing and risk-assessment skills.
• Ability to self-lead work tasks to completion.
• Proficient in MS Office (Word, Visio, PowerPoint, & Excel), Emission Master, SAP, and Smartsheet.
• Strong written, verbal, and interpersonal communication skills.
• Excellent presentation and adult learning skills.
• Ability to develop, perform, evaluate, and troubleshoot within a scientific discipline.
• Self-motivated and detail oriented.

Scientist II

Location: Worcester, MA

Work Arrangement: 100% onsite

Contract Duration: 12 months

Overview

We are seeking a highly motivated and talented Scientist II to join our In Vivo Antibody Discovery and Molecular Core team in Worcester, MA. This is a newly created role driven by increased workload, supporting a team of six scientists.

This R&D-focused position centers on high-throughput next generation sequencing (NGS), primarily working with human cells. The role involves upstream processing, including working with primary cells (p cells), DNA extraction, sequencing preparation, and data analysis, with results shared with downstream scientists.

Key Responsibilities

Experimental Design & Execution

• Independently design, execute, and interpret experiments utilizing microfluidics to amplify heavy and light chain genes and generate DNA libraries for deep sequencing of single B cells captured in droplet emulsions
• Understand project objectives and adapt experimental plans as needed while meeting timelines

Molecular Techniques

• Perform RNA isolation and DNA purification
• Amplify antibody heavy- and light-chain variable regions from single cells or lysates
• Prepare and submit DNA libraries for next generation sequencing (MiSeq/MiSeq i100)

Bioinformatics & Data Analysis

• Conduct sequencing data analysis of cells
• Perform in silico antibody genetic analysis and data visualization using standard and custom bioinformatics tools
• Utilize coding/data analysis at a basic to intermediate level (preferred)

Collaboration

• Present and discuss experimental findings with cross-functional teams
• Support multiple programs across the in vivo antibody discovery portfolio
• Work both independently and collaboratively while managing multiple projects

Qualifications

• 3–5 years of experience
• Hands-on experience with DNA sequencing (Illumina) – required
• Microfluidic experience – required
• Experience working with next generation sequencing (NGS)
• Molecular biology expertise
• DNA/RNA purification experience
• Primary cell (p cell) experience
• Data analysis background – preferred
• Basic to intermediate coding/data experience – preferred

Education

• Bachelor’s or Master’s degree required
• PhD is overqualified (OQ)

Required Skills & Experience

• Master’s degree in biology, immunology, cell/molecular biology, or related discipline with experience in single B cell sequencing research and 2+ years of relevant experience (MS)
• Demonstrated hands-on expertise in droplet microfluidics of single B cells and next generation sequencing of IgG variable heavy and light chains
• Familiarity with next generation sequencing platforms (Illumina MiSeq and MiSeq i100) and B cell genetic data analysis software/databases (FLASH, IgBlast, Usearch, IMGT)
• Experience in reverse transcription, RNA/DNA isolation and purification, overlap extension PCR, primer design, cDNA library generation, and gel electrophoresis
• Protein and cell detection methods experience (ELISA and/or FACS) – preferred

Additional Details

• Reason for Need: New role due to increased workload
• Team Size: 6